Table 6.
Overview of adverse events
| 12-Week double-blind period (SAF)a | |||
|---|---|---|---|
| TEAE, No. (%) | Placebo (n = 167) | Fezolinetant 30 mg (n = 166) | Fezolinetant 45 mg (n = 167) |
| TEAE | 54 (32.3) | 67 (40.4) | 60 (35.9) |
| Drug-related TEAE | 11 (6.6) | 24 (14.5) | 25 (15.0) |
| Serious TEAE | 0 | 3 (1.8)b | 2 (1.2)c |
| Drug-related serious TEAE | 0 | 0 | 0 |
| TEAE leading to permanent discontinuation of study drug | 1 (0.6)d | 2 (1.2)e | 5 (3.0)f |
| Drug-related TEAE leading to permanent discontinuation of study drug | 0 | 1 (0.6) | 5 (3.0) |
| Deaths | 0 | 0 | 0 |
| TEAEs by PT (≥ 2.0% for any group) | |||
| Upper respiratory tract infection | 7 (4.2) | 5 (3.0) | 5 (3.0) |
| Headache | 4 (2.4) | 5 (3.0) | 6 (3.6) |
| Dry mouth | 0 | 4 (2.4) | 4 (2.4) |
| Arthralgia | 1 (0.6) | 5 (3.0) | 1 (0.6) |
| Diarrhea | 4 (2.4) | 1 (0.6) | 2 (1.2) |
| Nasopharyngitis | 4 (2.4) | 3 (1.8) | 0 |
| Nausea | 0 | 3 (1.8) | 4 (2.4) |
| Weight increased | 1 (0.6) | 5 (3.0) | 1 (0.6) |
| TEAEs of special interest | |||
| Depression | 4 (2.4) | 3 (1.8) | 1 (0.6) |
| Liver test elevations | 0 | 2 (1.2) | 3 (1.8) |
| Wakefulness | 1 (0.6) | 3 (1.8) | 1 (0.6) |
| Uterine bleeding | 1 (0.6) | 1 (0.6) | 1 (0.6) |
| Bone fractures | 1 (0.6) | 1 (0.6) | 0 |
| Thrombocytopenia | 0 | 2 (1.2) | 0 |
| Potential abuse liability | 1 (0.6) | 0 | 0 |
| Endometrial hyperplasia/cancer or disordered proliferative endometrium | 0 | 0 | 0 |
| Effect on memory | 0 | 0 | 0 |
| Start of fezolinetant treatment (SAF-fezolinetant exposure)g | ||||
|---|---|---|---|---|
| TEAE, No. (%) | Fezolinetant 30 mg (n = 166) | Fezolinetant 45 mg (n = 167) | Placebo/Fezolinetant 30 mg (n = 76) | Placebo/Fezolinetant 45 mg (n = 75) |
| TEAE | 107 (64.5) | 106 (63.5) | 43 (56.6) | 45 (60.0) |
| Drug-related TEAE | 33 (19.9) | 30 (18.0) | 8 (10.5) | 8 (10.7) |
| Serious TEAE | 9 (5.4) | 8 (4.8) | 2 (2.6) | 4 (5.3) |
| Drug-related serious TEAE | 0 | 1 (0.6) | 0 | 1 (1.3) |
| TEAE leading to permanent discontinuation of study drug | 4 (2.4) | 7 (4.2) | 2 (2.6) | 3 (4.0) |
| Drug-related TEAE leading to permanent discontinuation of study drug | 1 (0.6) | 6 (3.6) | 1 (1.3) | 2 (2.7) |
| Deaths | 0 | 0 | 0 | 1 (1.3) |
| TEAEs by PT (≥ 4.0% for any group) | ||||
| COVID-19 | 9 (5.4) | 15 (9.0) | 4 (5.3) | 3 (4.0) |
| Headache | 8 (4.8) | 12 (7.2) | 1 (1.3) | 4 (5.3) |
| Arthralgia | 7 (4.2) | 4 (2.4) | 3 (3.9) | 2 (2.7) |
| Back pain | 5 (3.0) | 6 (3.6) | 2 (2.6) | 3 (4.0) |
| Upper respiratory tract infection | 7 (4.2) | 8 (4.8) | 1 (1.3) | 0 |
| Hot flush | 3 (1.8) | 7 (4.2) | 4 (5.3) | 0 |
| Hypertension | 5 (3.0) | 7 (4.2) | 1 (1.3) | 0 |
| Blood creatine phosphokinase increased | 2 (1.2) | 3 (1.8) | 1 (1.3) | 5 (6.7) |
| Weight increased | 8 (4.8) | 2 (1.2) | 1 (1.3) | 0 |
| Pain in extremity | 3 (1.8) | 1 (0.6) | 1 (1.3) | 3 (4.0) |
| Ear infection | 0 | 3 (1.8) | 1 (1.3) | 3 (4.0) |
| Gastroesophageal reflux disease | 2 (1.2) | 2 (1.2) | 0 | 3 (4.0) |
| Anxiety | 1 (0.6) | 0 | 0 | 3 (4.0) |
| TEAEs of special interest | ||||
| COVID-19 | 9 (5.4) | 16 (9.6) | 4 (5.3) | 4 (5.3) |
| Liver test elevations | 4 (2.4) | 9 (5.4) | 1 (1.3) | 1 (1.3) |
| Uterine bleeding | 6 (3.6) | 4 (2.4) | 0 | 0 |
| Depression | 3 (1.8) | 2 (1.2) | 0 | 1 (1.3) |
| Wakefulness | 3 (1.8) | 2 (1.2) | 0 | 0 |
| Bone fractures | 2 (1.2) | 1 (0.6) | 0 | 1 (1.3) |
| Endometrial hyperplasia/cancer or disordered proliferative endometrium | 1 (0.6) | 0 | 1 (1.3) | 1 (1.3) |
| Thrombocytopenia | 2 (1.2) | 0 | 0 | 0 |
| Effect on memory | 0 | 0 | 1 (1.3) | 0 |
| Potential abuse liability | 0 | 0 | 0 | 0 |
Data shown for the SAF (randomized participants who took ≥ 1 dose of study drug). In the double-blind period, 4 participants had confirmed and suspected cases of COVID-19 (1 receiving placebo, 2 receiving fezolinetant 30 mg, and 1 receiving fezolinetant 45 mg). A serious TEAE is a TEAE that, in the view of the investigator or sponsor, results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly/birth defect, requires inpatient hospitalization, results in discontinuation due to increases in liver enzymes, results in other medically important events.
Abbreviations: PT, preferred term; SAF, safety analysis set; TEAE, treatment-emergent adverse event.
For the double-blind period, data were collected from the first dose of study drug until week 12.
Atrial fibrillation in 1 participant, tooth infection in 1 participant, and COVID-19 in 1 participant.
Biliary dyskinesia in 1 participant and posterior tibial nerve injury in 1 participant.
Increased appetite and hot flash in 1 participant.
Fatigue and oropharyngeal pain in 1 participant and alexithymia in 1 participant.
Arthralgia in 1 participant; abdominal pain, hematochezia, nausea, vomiting, and colitis in 1 participant; international normalized ratio increased in 1 participant; nausea in 1 participant; and alanine aminotransferase increased in 1 participant.
For the extension period, data were collected from the first dose of study drug until week 52 for the fezolinetant groups and from week 13 to week 52 for the placebo/fezolinetant groups.