Trial Outcomes & Findings for X-82 to Treat Age-related Macular Degeneration (NCT NCT02348359)

NCT ID: NCT02348359

Last Updated: 2022-02-11

Results Overview

The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

157 participants

Primary outcome timeframe

Week 52

Results posted on

2022-02-11

Participant Flow

This study was conducted at 39 sites in the United States. There were 36 sites that screened subjects and 3 sites that did not screen any subjects. A total of 157 subjects were randomly assigned and treated in the study.

Participant milestones

Participant milestones
Measure	50 mg of X-82 Plus Ivt Anti-VEGF Prn Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	100 mg of X-82 Plus Ivt Anti-VEGF Prn Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	200 mg of X-82 Plus Ivt Anti-VEGF Prn Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	Placebo Plus Ivt Anti-VEGF Prn Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. Anti-VEGF Placebo
Overall Study STARTED	40	39	39	39
Overall Study COMPLETED	29	22	25	27
Overall Study NOT COMPLETED	11	17	14	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

X-82 to Treat Age-related Macular Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	50 mg of X-82 Plus Ivt Anti-VEGF Prn n=40 Participants Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	100 mg of X-82 Plus Ivt Anti-VEGF Prn n=39 Participants Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	200 mg of X-82 Plus Ivt Anti-VEGF Prn n=39 Participants Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	Placebo Plus Ivt Anti-VEGF Prn n=39 Participants Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. Anti-VEGF Placebo	Total n=157 Participants Total of all reporting groups
Age, Continuous	75.7 years STANDARD_DEVIATION 8.23 • n=99 Participants	73.5 years STANDARD_DEVIATION 8.33 • n=107 Participants	75.0 years STANDARD_DEVIATION 7.63 • n=206 Participants	75.9 years STANDARD_DEVIATION 7.65 • n=7 Participants	75.0 years STANDARD_DEVIATION 7.95 • n=31 Participants
Sex: Female, Male Female	22 Participants n=99 Participants	16 Participants n=107 Participants	18 Participants n=206 Participants	23 Participants n=7 Participants	79 Participants n=31 Participants
Sex: Female, Male Male	18 Participants n=99 Participants	23 Participants n=107 Participants	21 Participants n=206 Participants	16 Participants n=7 Participants	78 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	2 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) White	40 Participants n=99 Participants	38 Participants n=107 Participants	38 Participants n=206 Participants	38 Participants n=7 Participants	154 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Region of Enrollment United States	40 participants n=99 Participants	39 participants n=107 Participants	39 participants n=206 Participants	39 participants n=7 Participants	157 participants n=31 Participants
Best corrected visual acuity	72.3 Number of letters STANDARD_DEVIATION 9.41 • n=99 Participants	71.2 Number of letters STANDARD_DEVIATION 12.17 • n=107 Participants	71.9 Number of letters STANDARD_DEVIATION 13.17 • n=206 Participants	68.8 Number of letters STANDARD_DEVIATION 12.43 • n=7 Participants	71.0 Number of letters STANDARD_DEVIATION 11.83 • n=31 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Analysis restricted to subjects who completed 52 weeks of treatment

The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization.

Outcome measures

Outcome measures
Measure	50 mg of X-82 Plus Ivt Anti-VEGF Prn n=23 Participants Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	100 mg of X-82 Plus Ivt Anti-VEGF Prn n=19 Participants Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	200 mg of X-82 Plus Ivt Anti-VEGF Prn n=17 Participants Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	Placebo Plus Ivt Anti-VEGF Prn n=22 Participants Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. Anti-VEGF Placebo
Mean Change in Visual Acuity Score From Day -1 to Week52	0.2 number of letters Standard Deviation 4.14	-0.9 number of letters Standard Deviation 6.57	1.7 number of letters Standard Deviation 5.58	-0.3 number of letters Standard Deviation 10.63

Adverse Events

50 mg of X-82 Plus Ivt Anti-VEGF Prn

Serious events: 6 serious events

Other events: 39 other events

Deaths: 0 deaths

100 mg of X-82 Plus Ivt Anti-VEGF Prn

Serious events: 7 serious events

Other events: 38 other events

Deaths: 1 deaths

200 mg of X-82 Plus Ivt Anti-VEGF Prn

Serious events: 3 serious events

Other events: 37 other events

Deaths: 0 deaths

Placebo Plus Ivt Anti-VEGF Prn

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Vice President, Clinical and Regulatory

Brace Pharma Capital

Phone: 240-403-7153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	50 mg of X-82 Plus Ivt Anti-VEGF Prn n=40 participants at risk Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	100 mg of X-82 Plus Ivt Anti-VEGF Prn n=39 participants at risk Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	200 mg of X-82 Plus Ivt Anti-VEGF Prn n=39 participants at risk Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	Placebo Plus Ivt Anti-VEGF Prn n=39 participants at risk Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. Anti-VEGF Placebo
Cardiac disorders Myocardial infarction	2.5% 1/40 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Gastrointestinal disorders lower gastrointestinal hemorrhage	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
General disorders Chest pain	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Cardiac disorders sudden cardiac death	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Infections and infestations Endopthalmitis	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Infections and infestations Influenza	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Infections and infestations Pneumonia	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Infections and infestations Sepsis	2.5% 1/40 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Infections and infestations Urinary tract infection	2.5% 1/40 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Injury, poisoning and procedural complications Hip fracture	2.5% 1/40 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Metabolism and nutrition disorders Dehydration	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Metabolism and nutrition disorders Hypokalemia	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	2.5% 1/40 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.5% 1/40 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	2.5% 1/40 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B cell lymphoma	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	2.5% 1/40 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	2.5% 1/40 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Nervous system disorders Cerebral infarction	2.5% 1/40 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Nervous system disorders Syncope	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Vascular disorders Deep vein thrombosis	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Vascular disorders Hypertensive crisis	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • Number of events 1 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months

Other adverse events
Measure	50 mg of X-82 Plus Ivt Anti-VEGF Prn n=40 participants at risk Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	100 mg of X-82 Plus Ivt Anti-VEGF Prn n=39 participants at risk Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	200 mg of X-82 Plus Ivt Anti-VEGF Prn n=39 participants at risk Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. X-82 Anti-VEGF	Placebo Plus Ivt Anti-VEGF Prn n=39 participants at risk Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. Anti-VEGF Placebo
Psychiatric disorders Insomnia	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Renal and urinary disorders Haematuria	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Renal and urinary disorders Nephrolithiasis	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Respiratory, thoracic and mediastinal disorders Cough	2.5% 1/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	7.7% 3/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Skin and subcutaneous tissue disorders Hair color change	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	25.6% 10/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	33.3% 13/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Skin and subcutaneous tissue disorders Alopecia	2.5% 1/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	15.4% 6/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Vascular disorders Hypertension	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	10.3% 4/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	12.8% 5/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	7.7% 3/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Visual acuity reduced	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Cardiac disorders Atrioventricular block	7.5% 3/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	7.7% 3/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Cardiac disorders Supraventricular systole	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Conjunctival hemorrhage	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Vitreous detachment	7.5% 3/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Cataract	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Retinal hemorrhage	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Dry eye	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Neovascular age related macular degeneration	2.5% 1/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	7.7% 3/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Vitreous floaters	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Diplopia	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Eye irritation	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Photopsia	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Vision blurred	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Eye pain	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Eyelash discoloration	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Eye disorders Metamorphopsia	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Gastrointestinal disorders Diarrhoea	2.5% 1/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	10.3% 4/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	23.1% 9/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Gastrointestinal disorders nausea	15.0% 6/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Gastrointestinal disorders vomiting	7.5% 3/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Gastrointestinal disorders dyspepsia	2.5% 1/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	7.7% 3/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Gastrointestinal disorders abdominal discomfort	2.5% 1/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	7.7% 3/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Gastrointestinal disorders Constipation	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Gastrointestinal disorders Eructation	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
General disorders Fatigue	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	10.3% 4/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	15.4% 6/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
General disorders Oedema peripheral	2.5% 1/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	7.7% 3/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
General disorders Chest pain	0.00% 0/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	7.7% 3/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Infections and infestations Nasopharyngitis	17.5% 7/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	12.8% 5/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Infections and infestations Urinary tract infection	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	12.8% 5/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Infections and infestations Bronchitis	5.0% 2/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	7.7% 3/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	0.00% 0/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Infections and infestations Influenza	2.5% 1/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	7.7% 3/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Infections and infestations Sinusitis	2.5% 1/40 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	5.1% 2/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months	2.6% 1/39 • All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months