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Pressure testing when there are >3000 subjects and >5 arms #127

@LittleBeannie

Description

@LittleBeannie

Prompt Goal: Generate R code using the stats and dplyr/tidyr R packages to create two synthetic clinical trial datasets: forestly_adsl and forestly_adae.

Dataset Descriptions:

  1. forestly_adsl (Subject-Level Data):
    This dataset contains one record per patient.
    The primary patient identifier is USUBJID.
    The treatment group variable is TRT01A.
    Key Variables: USUBJID, SITEID, TRT01A, AGE, SEX, SAFFL, BMIBL, WEIGHTBL.

  2. forestly_adae (Adverse Event Data):
    This dataset contains records of adverse events for patients.
    A single patient (USUBJID) can have multiple records, representing multiple adverse events.
    Key Variables: USUBJID, SITEID, AGE, TRT01A, AEDECOD, AEREL, AESER, AEACN, AEOUT.

Code Generation Instructions:
Please generate R code to perform the following steps:

Part 1: Generate the forestly_adsl data.frame
Create a dataframe named forestly_adsl with 10000 rows and the following columns, generated according to these rules:

  • SITEID: Randomly sample from the list ["701", "702", "703", "704", "705", "706", "708", "709", "710"] with equal probability for each site.
  • USUBJID: Create a unique subject ID by concatenating the SITEID with a randomly generated 5-digit number (e.g., "701-01234"). Ensure all USUBJID values are unique.
  • TRT01A: This is a 6-arm study. Randomly assign each subject to one of the following groups with equal probability: "Group A", "Group B", "Group C", "Group D", "Group E", "Group F".
  • AGE: Generate a random integer between 30 and 80 (inclusive).
  • SEX: Randomly sample from ["F", "M"] with equal probability.
  • RACE: Randomly sample from ["WHITE" , "BLACK OR AFRICAN AMERICAN"] with equal probability.
  • SAFFL: (Safety Flag) Randomly sample from ["Y", "N"] with probabilities of 90% for "Y" and 10% for "N".
  • BMIBL: (Baseline BMI) Generate a random floating-point number between 18.0 and 40.0.
  • WEIGHTBL: (Baseline Weight) Generate a random integer between 40 and 120 (inclusive).

Part 2: Generate the forestly_adae data.frame
Create a second dataframe named forestly_adae. This dataframe should be generated based on the forestly_adsl data.
Determine the Number of Adverse Events per Subject:
For each subject in forestly_adsl, generate a random number of adverse events they will experience. This number should be between 0 and 10 (inclusive).

Create Records for Each Adverse Event:
Iterate through each subject from forestly_adsl and create the specified number of adverse event records for them.
The final forestly_adae will be the collection of all these records.
Define the Columns for forestly_adae:

  • USUBJID, SITEID, TRT01A, AGE: These values must be copied directly from the corresponding subject's record in the forestly_adsl DataFrame.
  • AEDECOD: (Adverse Event Term) Randomly sample from the following list of common adverse event terms: ["HEADACHE", "NAUSEA", "FATIGUE", "DIZZINESS", "DIARRHEA", "RASH", "FEVER"].
  • AEBODSYS: (Adverse Event Body Organ) It depends on the value of AEDECOD and follows the mapping rule below:
    AEDECOD AEBODSYS
    1 APPLICATION SITE ERYTHEMA GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    2 APPLICATION SITE PRURITUS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    3 DIARRHOEA GASTROINTESTINAL DISORDERS
    4 ERYTHEMA SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    6 ATRIOVENTRICULAR BLOCK SECOND DEGREE CARDIAC DISORDERS
    12 HIATUS HERNIA GASTROINTESTINAL DISORDERS
    14 UPPER RESPIRATORY TRACT INFECTION INFECTIONS AND INFESTATIONS
    15 BUNDLE BRANCH BLOCK LEFT CARDIAC DISORDERS
    17 PRURITUS GENERALISED SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    18 APPLICATION SITE VESICLES GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    23 PHARYNGOLARYNGEAL PAIN RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    24 NASAL CONGESTION RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    27 PRURITUS SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    28 LOCALISED INFECTION INFECTIONS AND INFESTATIONS
    31 MICTURITION URGENCY RENAL AND URINARY DISORDERS
    32 ARTHRALGIA MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
    33 CELLULITIS INFECTIONS AND INFESTATIONS
    36 APPLICATION SITE IRRITATION GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    40 FATIGUE GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    42 APPLICATION SITE DERMATITIS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    43 COUGH RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    44 URINARY TRACT INFECTION INFECTIONS AND INFESTATIONS
    45 PYREXIA GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    47 EYE SWELLING EYE DISORDERS
    48 EYE ALLERGY EYE DISORDERS
    49 EYE PRURITUS EYE DISORDERS
    77 INCREASED APPETITE METABOLISM AND NUTRITION DISORDERS
    93 URTICARIA SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    95 APPLICATION SITE URTICARIA GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    97 NASAL MUCOSA BIOPSY INVESTIGATIONS
    98 SECRETION DISCHARGE GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    103 PNEUMONIA INFECTIONS AND INFESTATIONS
    104 MUSCULAR WEAKNESS MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
    112 EYE LASER SURGERY SURGICAL AND MEDICAL PROCEDURES
    114 JOINT DISLOCATION INJURY, POISONING AND PROCEDURAL COMPLICATIONS
    115 SHOULDER PAIN MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
    116 INCONTINENCE RENAL AND URINARY DISORDERS
    118 SKIN LACERATION INJURY, POISONING AND PROCEDURAL COMPLICATIONS
    119 CONFUSIONAL STATE PSYCHIATRIC DISORDERS
    120 DYSPNOEA RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    121 SUDDEN DEATH GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    157 RASH ERYTHEMATOUS SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    181 ONYCHOMYCOSIS INFECTIONS AND INFESTATIONS
    182 CYST GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    186 DEPRESSED MOOD PSYCHIATRIC DISORDERS
    189 DYSPHONIA RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    202 NAUSEA GASTROINTESTINAL DISORDERS
    203 HEADACHE NERVOUS SYSTEM DISORDERS
    206 BACK PAIN MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
    221 HYPERHIDROSIS SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    239 WHITE BLOOD CELL COUNT INCREASED INVESTIGATIONS
    240 NEUTROPHIL COUNT INCREASED INVESTIGATIONS
    241 URINE ANALYSIS ABNORMAL INVESTIGATIONS
    245 RECTAL HAEMORRHAGE GASTROINTESTINAL DISORDERS
    248 SKIN IRRITATION SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    250 INSOMNIA PSYCHIATRIC DISORDERS
    261 CHILLS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    267 CATARACT OPERATION SURGICAL AND MEDICAL PROCEDURES
    269 OEDEMA PERIPHERAL GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    280 SOMNOLENCE NERVOUS SYSTEM DISORDERS
    282 DISORIENTATION PSYCHIATRIC DISORDERS
    283 DECREASED APPETITE METABOLISM AND NUTRITION DISORDERS
    295 GLAUCOMA EYE DISORDERS
    296 HYPOTENSION VASCULAR DISORDERS
    297 TACHYCARDIA CARDIAC DISORDERS
    300 MYOCARDIAL INFARCTION CARDIAC DISORDERS
    314 MALAISE GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    315 RASH SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    317 DIZZINESS NERVOUS SYSTEM DISORDERS
    319 CYSTITIS INFECTIONS AND INFESTATIONS
    320 VOMITING GASTROINTESTINAL DISORDERS
    322 EXCORIATION INJURY, POISONING AND PROCEDURAL COMPLICATIONS
    325 CONTUSION INJURY, POISONING AND PROCEDURAL COMPLICATIONS
    334 VERTIGO EAR AND LABYRINTH DISORDERS
    335 PALPITATIONS CARDIAC DISORDERS
    336 ELECTROCARDIOGRAM ST SEGMENT DEPRESSION INVESTIGATIONS
    337 WOLFF-PARKINSON-WHITE SYNDROME CARDIAC DISORDERS
    357 OEDEMA GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    360 INFLUENZA INFECTIONS AND INFESTATIONS
    362 NASOPHARYNGITIS INFECTIONS AND INFESTATIONS
    372 BLOOD GLUCOSE INCREASED INVESTIGATIONS
    391 VIRAL INFECTION INFECTIONS AND INFESTATIONS
    403 POLLAKIURIA RENAL AND URINARY DISORDERS
    404 FLATULENCE GASTROINTESTINAL DISORDERS
    408 PARKINSON'S DISEASE NERVOUS SYSTEM DISORDERS
    409 COMPLETED SUICIDE PSYCHIATRIC DISORDERS
    412 HYPERBILIRUBINAEMIA HEPATOBILIARY DISORDERS
    413 DYSPEPSIA GASTROINTESTINAL DISORDERS
    429 VENTRICULAR HYPERTROPHY CARDIAC DISORDERS
    431 ABDOMINAL PAIN GASTROINTESTINAL DISORDERS
    433 COLON CANCER NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
    436 ANXIETY PSYCHIATRIC DISORDERS
    440 IRRITABILITY PSYCHIATRIC DISORDERS
    458 SINUS ARRHYTHMIA CARDIAC DISORDERS
    459 BLOOD CREATINE PHOSPHOKINASE INCREASED INVESTIGATIONS
    460 POSTNASAL DRIP RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    464 CONJUNCTIVITIS EYE DISORDERS
    467 STUPOR NERVOUS SYSTEM DISORDERS
    468 TRANSIENT ISCHAEMIC ATTACK NERVOUS SYSTEM DISORDERS
    469 VISION BLURRED EYE DISORDERS
    476 SINUS BRADYCARDIA CARDIAC DISORDERS
    478 HEART RATE IRREGULAR INVESTIGATIONS
    484 AGITATION PSYCHIATRIC DISORDERS
    503 HEART RATE INCREASED INVESTIGATIONS
    510 MUSCLE SPASMS MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
    511 VENTRICULAR EXTRASYSTOLES CARDIAC DISORDERS
    519 HOT FLUSH VASCULAR DISORDERS
    524 CONSTIPATION GASTROINTESTINAL DISORDERS
    525 ATRIAL HYPERTROPHY CARDIAC DISORDERS
    531 PAIN IN EXTREMITY MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
    533 APPLICATION SITE SWELLING GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    561 EPISTAXIS RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    564 APPLICATION SITE WARMTH GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    620 ELECTROCARDIOGRAM T WAVE INVERSION INVESTIGATIONS
    637 BLOOD URINE PRESENT INVESTIGATIONS
    638 CYSTOSCOPY INVESTIGATIONS
    639 BENIGN PROSTATIC HYPERPLASIA REPRODUCTIVE SYSTEM AND BREAST DISORDERS
    642 DEHYDRATION METABOLISM AND NUTRITION DISORDERS
    644 ORTHOSTATIC HYPOTENSION VASCULAR DISORDERS
    646 HEMIANOPIA HOMONYMOUS NERVOUS SYSTEM DISORDERS
    652 DIABETES MELLITUS METABOLISM AND NUTRITION DISORDERS
    658 DRUG ERUPTION SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    682 SYNCOPE NERVOUS SYSTEM DISORDERS
    683 APPLICATION SITE BLEEDING GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    688 BLOOD ALKALINE PHOSPHATASE INCREASED INVESTIGATIONS
    707 HAEMOPTYSIS RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    708 RALES RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    718 SKIN EXFOLIATION SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    731 APPLICATION SITE INDURATION GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    734 FALL INJURY, POISONING AND PROCEDURAL COMPLICATIONS
    745 ARTHRITIS MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
    762 COMPLEX PARTIAL SEIZURES NERVOUS SYSTEM DISORDERS
    765 ATRIOVENTRICULAR BLOCK FIRST DEGREE CARDIAC DISORDERS
    777 COLD SWEAT SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    787 ATRIAL FIBRILLATION CARDIAC DISORDERS
    788 CARDIAC FAILURE CONGESTIVE CARDIAC DISORDERS
    789 HYPONATRAEMIA METABOLISM AND NUTRITION DISORDERS
    799 BLISTER SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    814 APPLICATION SITE DESQUAMATION GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    815 HIP FRACTURE INJURY, POISONING AND PROCEDURAL COMPLICATIONS
    816 DELUSION PSYCHIATRIC DISORDERS
    817 PSYCHOMOTOR HYPERACTIVITY NERVOUS SYSTEM DISORDERS
    819 SUPRAVENTRICULAR TACHYCARDIA CARDIAC DISORDERS
    826 ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED INVESTIGATIONS
    839 EAR INFECTION INFECTIONS AND INFESTATIONS
    840 GLOSSITIS GASTROINTESTINAL DISORDERS
    842 TINNITUS EAR AND LABYRINTH DISORDERS
    843 PARAESTHESIA ORAL NERVOUS SYSTEM DISORDERS
    845 SUPRAVENTRICULAR EXTRASYSTOLES CARDIAC DISORDERS
    850 RASH PRURITIC SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    853 CONJUNCTIVAL HAEMORRHAGE EYE DISORDERS
    854 CERUMEN IMPACTION EAR AND LABYRINTH DISORDERS
    871 DYSURIA RENAL AND URINARY DISORDERS
    874 ASTHENIA GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    878 PELVIC PAIN REPRODUCTIVE SYSTEM AND BREAST DISORDERS
    879 GASTROENTERITIS VIRAL INFECTIONS AND INFESTATIONS
    880 GASTROOESOPHAGEAL REFLUX DISEASE GASTROINTESTINAL DISORDERS
    881 VAGINAL MYCOSIS INFECTIONS AND INFESTATIONS
    882 CERVICITIS INFECTIONS AND INFESTATIONS
    902 BUNDLE BRANCH BLOCK RIGHT CARDIAC DISORDERS
    908 BRONCHITIS INFECTIONS AND INFESTATIONS
    934 EAR PAIN EAR AND LABYRINTH DISORDERS
    942 DERMATITIS CONTACT SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    945 NEPHROLITHIASIS RENAL AND URINARY DISORDERS
    959 EMPHYSEMA RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    974 RESTLESSNESS PSYCHIATRIC DISORDERS
    975 LETHARGY NERVOUS SYSTEM DISORDERS
    980 ATRIAL FLUTTER CARDIAC DISORDERS
    982 VENTRICULAR SEPTAL DEFECT CONGENITAL, FAMILIAL AND GENETIC DISORDERS
    990 MALIGNANT FIBROUS HISTIOCYTOMA NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
    1001 SWELLING GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    1003 HYPERSENSITIVITY IMMUNE SYSTEM DISORDERS
    1021 ULCER GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    1043 ENURESIS RENAL AND URINARY DISORDERS
    1046 RHINORRHOEA RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    1060 WOUND INJURY, POISONING AND PROCEDURAL COMPLICATIONS
    1077 ALOPECIA SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    1098 PAIN GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    1104 INFLAMMATION GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    1117 BRADYCARDIA CARDIAC DISORDERS
    1123 FOOD CRAVING METABOLISM AND NUTRITION DISORDERS
    1129 BODY TEMPERATURE INCREASED INVESTIGATIONS
    1130 HYPERTENSION VASCULAR DISORDERS
    1133 BALANCE DISORDER NERVOUS SYSTEM DISORDERS
    1140 COORDINATION ABNORMAL NERVOUS SYSTEM DISORDERS
    1147 APPLICATION SITE DISCOLOURATION GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    1152 DYSPHAGIA GASTROINTESTINAL DISORDERS
    1157 SKIN ULCER SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    1159 DERMATITIS ATOPIC SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    1166 APPLICATION SITE REACTION GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
  • AEREL: (Causality/Relationship to Drug) Randomly sample from ["RELATED", "NOT RELATED"] with probabilities of 70% for "RELATED" and 30% for "NOT RELATED".
  • AESER: (Serious Event) Randomly sample from ["Y", "N"] with probabilities of 20% for "Y" and 80% for "N".
  • AEOUT: (Outcome of Event) Randomly sample from ["RECOVERED/RESOLVED", "NOT RECOVERED/NOT RESOLVED", "FATAL"] with probabilities of 80%, 10%, and 10% respectively.
  • AEACN: (Action Taken with Study Treatment) Randomly sample from ["DOSE NOT CHANGED", "DRUG INTERRUPTED", "DOSE REDUCED", "DRUG WITHDRAWN", "NOT APPLICABLE"] with equal probability.

Part 3: Final Output
Output the code to generate the above 2 data frame.

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