Table 3.
Treatment-Emergent Adverse Events (TEAEs)
| Crinecerfont (N=122) |
Placebo (N=59) |
|
|---|---|---|
| TEAE summary – no. (%) | ||
| Any TEAE | 101 (82.8) | 48 (81.4) |
| Any serious TEAE | 4 (3.3)* | 0 |
| Any TEAE leading to study drug discontinuation | 4 (3.3)† | 0 |
| Any TEAE leading to study discontinuation | 4 (3.3)† | 0 |
| Any TEAE resulting in death | 0 | 0 |
| TEAE severity – no. (%)‡ | ||
| Mild | 62 (50.8) | 30 (50.8) |
| Moderate | 36 (29.5) | 18 (30.5) |
| Severe | 3 (2.5) | 0 |
| Common TEAEs – no. (%)§ | ||
| Fatigue | 30 (24.6) | 9 (15.3) |
| Headache | 19 (15.6) | 9 (15.3) |
| Coronavirus infection | 17 (13.9) | 5 (8.5) |
| Upper respiratory tract infection | 11 (9.0) | 7 (11.9) |
| Diarrhea | 10 (8.2) | 5 (8.5) |
| Dizziness | 10 (8.2) | 2 (3.4) |
| Nausea | 10 (8.2) | 5 (8.5) |
| Arthralgia | 9 (7.4) | 0 |
| Back pain | 7 (5.7) | 2 (3.4) |
| Pyrexia | 7 (5.7) | 6 (10.2) |
| Blood creatine phosphokinase increased | 6 (4.9) | 2 (3.4) |
| Nasopharyngitis | 6 (4.9) | 8 (13.6) |
| Vomiting | 6 (4.9) | 5 (8.5) |
| Decreased appetite | 5 (4.1) | 1 (1.7) |
| Gastroenteritis | 5 (4.1) | 1 (1.7) |
| Influenza | 5 (4.1) | 2 (3.4) |
Due to acute cholecystitis (n=1), groin abscess and cellulitis (n=1), acute adrenocortical insufficiency (n=1), and presyncope (n=1). All serious TEAEs were assessed by the investigator as unlikely related to study treatment.
Due to dyspepsia, nausea and vomiting (n=1), gastric ulcer (n=1), apathy and restlessness (n=1), and rash (n=1). All adverse events that started in the double-blind period and resulted in study treatment discontinuation (regardless of when the subject discontinued study treatment) are presented. Only 1 adverse event that started in the double-blind period resulted in study treatment discontinuation during the double-blind period (gastric ulcer).
Maximum severity, as judged by the study investigator.
Reported in ≥5 participants (>4%) receiving crinecerfont.
Abbreviations: TEAE, treatment-emergent adverse events.