Trial Outcomes & Findings for Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection (NCT NCT04167670)
NCT ID: NCT04167670
Last Updated: 2022-04-05
Results Overview
H pylori eradication was determined by the \^13C-UBT test.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1046 participants
Primary outcome timeframe
Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Results posted on
2022-04-05
Participant Flow
1046 participants were randomized at 103 study sites, including 71 in the United States and 32 in Europe.
A \^13C-urea breath test (\^13C-UBT) was performed within 34 days prior to treatment to establish Helicobacter pylori (H pylori) infection status. 6 gastric mucosal biopsy specimens were collected to determine resistance of bacteria to clarithromycin, amoxicillin, and metronidazole antibiotics and to document H pylori infection. 3385 participants were screened, 2339 of which were screen failures. 1046 participants were randomized and 1039 received at least 1 dose of the study drugs.
Participant milestones
| Measure |
Vonoprazan Dual Therapy
Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14.
|
Vonoprazan Triple Therapy
Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
Lansoprazole Triple Therapy
Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
|---|---|---|---|
|
Overall Study
STARTED
|
349
|
349
|
348
|
|
Overall Study
Received Study Drugs
|
348
|
346
|
345
|
|
Overall Study
COMPLETED
|
334
|
331
|
334
|
|
Overall Study
NOT COMPLETED
|
15
|
18
|
14
|
Reasons for withdrawal
| Measure |
Vonoprazan Dual Therapy
Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14.
|
Vonoprazan Triple Therapy
Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
Lansoprazole Triple Therapy
Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
|---|---|---|---|
|
Overall Study
Pretreatment Event, Adverse Event, or Serious Adverse Event
|
1
|
7
|
4
|
|
Overall Study
Significant protocol deviation
|
3
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
3
|
|
Overall Study
Voluntary Withdrawal
|
0
|
1
|
1
|
|
Overall Study
Withdrawal of Consent
|
4
|
1
|
3
|
|
Overall Study
Miscellaneous
|
7
|
5
|
3
|
Baseline Characteristics
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection
Baseline characteristics by cohort
| Measure |
Vonoprazan Dual Therapy
n=349 Participants
Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14.
|
Vonoprazan Triple Therapy
n=349 Participants
Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
Lansoprazole Triple Therapy
n=348 Participants
Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
Total
n=1046 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 13.47 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 13.88 • n=7 Participants
|
51.6 years
STANDARD_DEVIATION 13.61 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 13.65 • n=4 Participants
|
|
Sex: Female, Male
Female
|
210 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
652 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
394 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
95 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
283 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
251 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
759 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
316 Participants
n=5 Participants
|
307 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
935 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
22 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)Population: Modified Intent-to-Treat Primary (MITTp) Analysis Set - All participants randomized into the study who had a H pylori infection documented by \^13C-UBT and biopsy (ie, culture or histology) at baseline and did not have a clarithromycin- or amoxicillin-resistant strain of H pylori at baseline.
H pylori eradication was determined by the \^13C-UBT test.
Outcome measures
| Measure |
Vonoprazan Dual Therapy
n=265 Participants
Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14.
|
Vonoprazan Triple Therapy
n=262 Participants
Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
Lansoprazole Triple Therapy
n=255 Participants
Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
|---|---|---|---|
|
Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants Without a Clarithromycin- or Amoxicillin-resistant Strain of H Pylori at Baseline
|
78.5 percentage of participants
|
84.7 percentage of participants
|
78.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)Population: All participants randomized into the study who had H pylori infection documented by \^13C-UBT and biopsy (ie, culture or histology) at baseline and had a clarithromycin-resistant strain of H pylori at baseline.
H pylori eradication was determined by the \^13C-UBT test.
Outcome measures
| Measure |
Vonoprazan Dual Therapy
n=56 Participants
Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14.
|
Vonoprazan Triple Therapy
n=73 Participants
Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
Lansoprazole Triple Therapy
n=72 Participants
Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
|---|---|---|---|
|
Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline
|
69.6 percentage of participants
|
65.8 percentage of participants
|
31.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)Population: Modified Intent-to-Treat (MITT) Analysis Set - All participants randomized into the study who had H pylori infection documented by \^13C-UBT and biopsy (ie, culture or histology) at baseline.
H pylori eradication was determined by the \^13C-UBT test.
Outcome measures
| Measure |
Vonoprazan Dual Therapy
n=324 Participants
Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14.
|
Vonoprazan Triple Therapy
n=338 Participants
Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
Lansoprazole Triple Therapy
n=330 Participants
Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
|---|---|---|---|
|
Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication
|
77.2 percentage of participants
|
80.8 percentage of participants
|
68.5 percentage of participants
|
Adverse Events
Vonoprazan Dual Therapy
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Vonoprazan Triple Therapy
Serious events: 6 serious events
Other events: 27 other events
Deaths: 2 deaths
Lansoprazole Triple Therapy
Serious events: 3 serious events
Other events: 48 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Vonoprazan Dual Therapy
n=348 participants at risk
Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14.
|
Vonoprazan Triple Therapy
n=346 participants at risk
Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
Lansoprazole Triple Therapy
n=345 participants at risk
Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.29%
1/348 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/346 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/345 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/348 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.29%
1/346 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/345 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/348 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.29%
1/346 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/345 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Infections and infestations
Corona virus infection
|
0.29%
1/348 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.29%
1/346 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/345 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/348 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/346 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.29%
1/345 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.29%
1/348 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/346 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/345 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Gastrointestinal disorders
Duodenal polyp
|
0.00%
0/348 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.29%
1/346 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/345 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.29%
1/348 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/346 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/345 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/348 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/346 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.29%
1/345 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/348 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.29%
1/346 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/345 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.29%
1/348 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/346 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/345 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/348 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.29%
1/346 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/345 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.29%
1/348 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/346 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/345 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/348 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.00%
0/346 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
0.29%
1/345 • Number of events 1 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
Other adverse events
| Measure |
Vonoprazan Dual Therapy
n=348 participants at risk
Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14.
|
Vonoprazan Triple Therapy
n=346 participants at risk
Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
Lansoprazole Triple Therapy
n=345 participants at risk
Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
18/348 • Number of events 18 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
4.0%
14/346 • Number of events 14 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
9.6%
33/345 • Number of events 33 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
|
Nervous system disorders
Dysgeusia
|
0.57%
2/348 • Number of events 2 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
4.3%
15/346 • Number of events 15 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
6.1%
21/345 • Number of events 21 • Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Safety Analysis Set - All participants who received at least 1 dose of study drugs.
|
Additional Information
Phathom Medical Information
Phathom Pharmaceuticals, Inc.
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER