Trial Outcomes & Findings for Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications (NCT NCT01227967)
NCT ID: NCT01227967
Last Updated: 2019-02-04
Results Overview
The central laboratory performed a qualitative PCR test on the NP sample from Day 0 in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
881 participants
Primary outcome timeframe
At Day 3
Results posted on
2019-02-04
Participant Flow
Outpatient or hospitalized participants at high risk for complications and morbidity, diagnosed with influenza by rapid antigen or PCR were recruited at 65 sites from 5 countries: 52 from the U.S., 2 from Australia, 3 from Mexico, and 4 each in Thailand and Argentina, between March 2011 to April 2016.
Eight hundred eighty-one subjects were enrolled per protocol (signed consent). Two hundred fifty-one subjects were excluded during screening and did not participate in any other aspect of the trial. Three subjects were randomized improperly because they were given study drug kit prior to the randomization.
Participant milestones
| Measure |
Combination Therapy
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
314
|
316
|
|
Overall Study
COMPLETED
|
298
|
303
|
|
Overall Study
NOT COMPLETED
|
16
|
13
|
Reasons for withdrawal
| Measure |
Combination Therapy
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Never Started Treatment
|
0
|
4
|
|
Overall Study
Taking Additional Antiviral Drug
|
1
|
0
|
Baseline Characteristics
The results are for the 454 participants with a confirmed positive test for influenza on a Day 0 sample from the central laboratory using a RT-PCR for influenza type and subtype.
Baseline characteristics by cohort
| Measure |
Combination Therapy
n=314 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
Total
n=626 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=314 Participants
|
4 Participants
n=312 Participants
|
5 Participants
n=626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
252 Participants
n=314 Participants
|
241 Participants
n=312 Participants
|
493 Participants
n=626 Participants
|
|
Age, Categorical
>=65 years
|
61 Participants
n=314 Participants
|
67 Participants
n=312 Participants
|
128 Participants
n=626 Participants
|
|
Age, Continuous
|
49.5 years
n=314 Participants
|
49.5 years
n=312 Participants
|
49.5 years
n=626 Participants
|
|
Sex: Female, Male
Female
|
187 Participants
n=314 Participants
|
198 Participants
n=312 Participants
|
385 Participants
n=626 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=314 Participants
|
114 Participants
n=312 Participants
|
241 Participants
n=626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=314 Participants
|
58 Participants
n=312 Participants
|
113 Participants
n=626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
258 Participants
n=314 Participants
|
254 Participants
n=312 Participants
|
512 Participants
n=626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=314 Participants
|
0 Participants
n=312 Participants
|
1 Participants
n=626 Participants
|
|
Race/Ethnicity, Customized
White
|
203 Participants
n=314 Participants
|
189 Participants
n=312 Participants
|
392 Participants
n=626 Participants
|
|
Race/Ethnicity, Customized
Asian
|
70 Participants
n=314 Participants
|
73 Participants
n=312 Participants
|
143 Participants
n=626 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=314 Participants
|
25 Participants
n=312 Participants
|
43 Participants
n=626 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
1 Participants
n=314 Participants
|
2 Participants
n=312 Participants
|
3 Participants
n=626 Participants
|
|
Race/Ethnicity, Customized
Race not available to clinic
|
21 Participants
n=314 Participants
|
21 Participants
n=312 Participants
|
42 Participants
n=626 Participants
|
|
Race/Ethnicity, Customized
Subject does not want to report
|
1 Participants
n=314 Participants
|
1 Participants
n=312 Participants
|
2 Participants
n=626 Participants
|
|
Race/Ethnicity, Customized
Subject does not know
|
0 Participants
n=314 Participants
|
1 Participants
n=312 Participants
|
1 Participants
n=626 Participants
|
|
Region of Enrollment
Argentina
|
12 participants
n=314 Participants
|
10 participants
n=312 Participants
|
22 participants
n=626 Participants
|
|
Region of Enrollment
United States
|
220 participants
n=314 Participants
|
216 participants
n=312 Participants
|
436 participants
n=626 Participants
|
|
Region of Enrollment
Mexico
|
17 participants
n=314 Participants
|
18 participants
n=312 Participants
|
35 participants
n=626 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=314 Participants
|
2 participants
n=312 Participants
|
2 participants
n=626 Participants
|
|
Region of Enrollment
Thailand
|
65 participants
n=314 Participants
|
66 participants
n=312 Participants
|
131 participants
n=626 Participants
|
|
Influenza Diagnostic Test by Local Testing
RT-PCR/PCR
|
33 Participants
n=314 Participants
|
30 Participants
n=312 Participants
|
63 Participants
n=626 Participants
|
|
Influenza Diagnostic Test by Local Testing
Rapid antigen test
|
281 Participants
n=314 Participants
|
281 Participants
n=312 Participants
|
562 Participants
n=626 Participants
|
|
Influenza Diagnostic Test by Local Testing
Isothermal nucleic acid amplification technology
|
0 Participants
n=314 Participants
|
1 Participants
n=312 Participants
|
1 Participants
n=626 Participants
|
|
Positive Influenza Test by Local Testing
|
314 Participants
n=314 Participants
|
312 Participants
n=312 Participants
|
626 Participants
n=626 Participants
|
|
Result of Influenza Test By Local Testing
Influenza A/H1N1
|
13 Participants
n=314 Participants
|
14 Participants
n=312 Participants
|
27 Participants
n=626 Participants
|
|
Result of Influenza Test By Local Testing
Influenza A/H3N2
|
1 Participants
n=314 Participants
|
1 Participants
n=312 Participants
|
2 Participants
n=626 Participants
|
|
Result of Influenza Test By Local Testing
Influenza A unsubtypable
|
29 Participants
n=314 Participants
|
22 Participants
n=312 Participants
|
51 Participants
n=626 Participants
|
|
Result of Influenza Test By Local Testing
Influenza A not typed
|
180 Participants
n=314 Participants
|
180 Participants
n=312 Participants
|
360 Participants
n=626 Participants
|
|
Result of Influenza Test By Local Testing
Influenza B
|
75 Participants
n=314 Participants
|
80 Participants
n=312 Participants
|
155 Participants
n=626 Participants
|
|
Result of Influenza Test By Local Testing
Influenza positive (unknown A or B)
|
10 Participants
n=314 Participants
|
5 Participants
n=312 Participants
|
15 Participants
n=626 Participants
|
|
Result of Influenza Test By Local Testing
Multiple types/subtypes
|
6 Participants
n=314 Participants
|
10 Participants
n=312 Participants
|
16 Participants
n=626 Participants
|
|
Confirmed Influenza Infection Status By Central Testing
Yes
|
230 Participants
n=314 Participants
|
224 Participants
n=312 Participants
|
454 Participants
n=626 Participants
|
|
Confirmed Influenza Infection Status By Central Testing
No
|
84 Participants
n=314 Participants
|
88 Participants
n=312 Participants
|
172 Participants
n=626 Participants
|
|
Influenza Type/Subtype By Central Testing
Influenza A/H3N2
|
126 Participants
n=314 Participants
|
118 Participants
n=312 Participants
|
244 Participants
n=626 Participants
|
|
Influenza Type/Subtype By Central Testing
Influenza A/H1N1
|
55 Participants
n=314 Participants
|
49 Participants
n=312 Participants
|
104 Participants
n=626 Participants
|
|
Influenza Type/Subtype By Central Testing
Influenza B
|
49 Participants
n=314 Participants
|
57 Participants
n=312 Participants
|
106 Participants
n=626 Participants
|
|
Influenza Type/Subtype By Central Testing
Negative
|
83 Participants
n=314 Participants
|
86 Participants
n=312 Participants
|
169 Participants
n=626 Participants
|
|
Influenza Type/Subtype By Central Testing
Missing
|
1 Participants
n=314 Participants
|
2 Participants
n=312 Participants
|
3 Participants
n=626 Participants
|
|
Quantitative PCR Viral Shedding
|
6.4 log10 copies/mL
n=230 Participants • The results are for the 454 participants with a confirmed positive test for influenza on a Day 0 sample from the central laboratory using a RT-PCR for influenza type and subtype.
|
6.7 log10 copies/mL
n=224 Participants • The results are for the 454 participants with a confirmed positive test for influenza on a Day 0 sample from the central laboratory using a RT-PCR for influenza type and subtype.
|
6.5 log10 copies/mL
n=454 Participants • The results are for the 454 participants with a confirmed positive test for influenza on a Day 0 sample from the central laboratory using a RT-PCR for influenza type and subtype.
|
|
Presence of fever
Yes
|
94 Participants
n=314 Participants
|
93 Participants
n=312 Participants
|
187 Participants
n=626 Participants
|
|
Presence of fever
No
|
216 Participants
n=314 Participants
|
216 Participants
n=312 Participants
|
432 Participants
n=626 Participants
|
|
Presence of fever
Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Symptom Score
Cough · Absent
|
18 Participants
n=314 Participants
|
14 Participants
n=312 Participants
|
32 Participants
n=626 Participants
|
|
Symptom Score
Cough · Mild
|
68 Participants
n=314 Participants
|
86 Participants
n=312 Participants
|
154 Participants
n=626 Participants
|
|
Symptom Score
Cough · Moderate
|
139 Participants
n=314 Participants
|
130 Participants
n=312 Participants
|
269 Participants
n=626 Participants
|
|
Symptom Score
Cough · Severe
|
85 Participants
n=314 Participants
|
78 Participants
n=312 Participants
|
163 Participants
n=626 Participants
|
|
Symptom Score
Cough · Missing
|
4 Participants
n=314 Participants
|
4 Participants
n=312 Participants
|
8 Participants
n=626 Participants
|
|
Symptom Score
Fatigue · Absent
|
28 Participants
n=314 Participants
|
15 Participants
n=312 Participants
|
43 Participants
n=626 Participants
|
|
Symptom Score
Fatigue · Mild
|
33 Participants
n=314 Participants
|
43 Participants
n=312 Participants
|
76 Participants
n=626 Participants
|
|
Symptom Score
Fatigue · Moderate
|
117 Participants
n=314 Participants
|
105 Participants
n=312 Participants
|
222 Participants
n=626 Participants
|
|
Symptom Score
Fatigue · Severe
|
132 Participants
n=314 Participants
|
145 Participants
n=312 Participants
|
277 Participants
n=626 Participants
|
|
Symptom Score
Fatigue · Missing
|
4 Participants
n=314 Participants
|
4 Participants
n=312 Participants
|
8 Participants
n=626 Participants
|
|
Symptom Score
Feverishness · Absent
|
70 Participants
n=314 Participants
|
62 Participants
n=312 Participants
|
132 Participants
n=626 Participants
|
|
Symptom Score
Feverishness · Mild
|
61 Participants
n=314 Participants
|
68 Participants
n=312 Participants
|
129 Participants
n=626 Participants
|
|
Symptom Score
Feverishness · Moderate
|
111 Participants
n=314 Participants
|
98 Participants
n=312 Participants
|
209 Participants
n=626 Participants
|
|
Symptom Score
Feverishness · Severe
|
68 Participants
n=314 Participants
|
80 Participants
n=312 Participants
|
148 Participants
n=626 Participants
|
|
Symptom Score
Feverishness · Missing
|
4 Participants
n=314 Participants
|
4 Participants
n=312 Participants
|
8 Participants
n=626 Participants
|
|
Symptom Score
Diarrhea · Absent
|
231 Participants
n=314 Participants
|
253 Participants
n=312 Participants
|
484 Participants
n=626 Participants
|
|
Symptom Score
Diarrhea · Mild
|
36 Participants
n=314 Participants
|
26 Participants
n=312 Participants
|
62 Participants
n=626 Participants
|
|
Symptom Score
Diarrhea · Moderate
|
26 Participants
n=314 Participants
|
20 Participants
n=312 Participants
|
46 Participants
n=626 Participants
|
|
Symptom Score
Diarrhea · Severe
|
15 Participants
n=314 Participants
|
10 Participants
n=312 Participants
|
25 Participants
n=626 Participants
|
|
Symptom Score
Diarrhea · Missing
|
6 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
9 Participants
n=626 Participants
|
|
Symptom Score
Muscle aches · Absent
|
44 Participants
n=314 Participants
|
30 Participants
n=312 Participants
|
74 Participants
n=626 Participants
|
|
Symptom Score
Muscle aches · Mild
|
51 Participants
n=314 Participants
|
56 Participants
n=312 Participants
|
107 Participants
n=626 Participants
|
|
Symptom Score
Muscle aches · Moderate
|
100 Participants
n=314 Participants
|
99 Participants
n=312 Participants
|
199 Participants
n=626 Participants
|
|
Symptom Score
Muscle aches · Severe
|
115 Participants
n=314 Participants
|
124 Participants
n=312 Participants
|
239 Participants
n=626 Participants
|
|
Symptom Score
Muscle aches · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Symptom Score
Vomiting · Absent
|
268 Participants
n=314 Participants
|
269 Participants
n=312 Participants
|
537 Participants
n=626 Participants
|
|
Symptom Score
Vomiting · Mild
|
18 Participants
n=314 Participants
|
18 Participants
n=312 Participants
|
36 Participants
n=626 Participants
|
|
Symptom Score
Vomiting · Moderate
|
16 Participants
n=314 Participants
|
12 Participants
n=312 Participants
|
28 Participants
n=626 Participants
|
|
Symptom Score
Vomiting · Severe
|
6 Participants
n=314 Participants
|
9 Participants
n=312 Participants
|
15 Participants
n=626 Participants
|
|
Symptom Score
Vomiting · Missing
|
6 Participants
n=314 Participants
|
4 Participants
n=312 Participants
|
10 Participants
n=626 Participants
|
|
Symptom Score
Headache · Absent
|
60 Participants
n=314 Participants
|
55 Participants
n=312 Participants
|
115 Participants
n=626 Participants
|
|
Symptom Score
Headache · Mild
|
76 Participants
n=314 Participants
|
81 Participants
n=312 Participants
|
157 Participants
n=626 Participants
|
|
Symptom Score
Headache · Moderate
|
99 Participants
n=314 Participants
|
99 Participants
n=312 Participants
|
198 Participants
n=626 Participants
|
|
Symptom Score
Headache · Severe
|
75 Participants
n=314 Participants
|
74 Participants
n=312 Participants
|
149 Participants
n=626 Participants
|
|
Symptom Score
Headache · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Symptom Score
Nausea · Absent
|
197 Participants
n=314 Participants
|
198 Participants
n=312 Participants
|
395 Participants
n=626 Participants
|
|
Symptom Score
Nausea · Mild
|
54 Participants
n=314 Participants
|
51 Participants
n=312 Participants
|
105 Participants
n=626 Participants
|
|
Symptom Score
Nausea · Moderate
|
38 Participants
n=314 Participants
|
35 Participants
n=312 Participants
|
73 Participants
n=626 Participants
|
|
Symptom Score
Nausea · Severe
|
19 Participants
n=314 Participants
|
24 Participants
n=312 Participants
|
43 Participants
n=626 Participants
|
|
Symptom Score
Nausea · Missing
|
6 Participants
n=314 Participants
|
4 Participants
n=312 Participants
|
10 Participants
n=626 Participants
|
|
Symptom Score
Sore throat · Absent
|
80 Participants
n=314 Participants
|
80 Participants
n=312 Participants
|
160 Participants
n=626 Participants
|
|
Symptom Score
Sore throat · Mild
|
94 Participants
n=314 Participants
|
91 Participants
n=312 Participants
|
185 Participants
n=626 Participants
|
|
Symptom Score
Sore throat · Moderate
|
102 Participants
n=314 Participants
|
91 Participants
n=312 Participants
|
193 Participants
n=626 Participants
|
|
Symptom Score
Sore throat · Severe
|
34 Participants
n=314 Participants
|
47 Participants
n=312 Participants
|
81 Participants
n=626 Participants
|
|
Symptom Score
Sore throat · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Symptom Score
Stuffy nose · Absent
|
82 Participants
n=314 Participants
|
66 Participants
n=312 Participants
|
148 Participants
n=626 Participants
|
|
Symptom Score
Stuffy nose · Mild
|
62 Participants
n=314 Participants
|
68 Participants
n=312 Participants
|
130 Participants
n=626 Participants
|
|
Symptom Score
Stuffy nose · Moderate
|
107 Participants
n=314 Participants
|
96 Participants
n=312 Participants
|
203 Participants
n=626 Participants
|
|
Symptom Score
Stuffy nose · Severe
|
59 Participants
n=314 Participants
|
78 Participants
n=312 Participants
|
137 Participants
n=626 Participants
|
|
Symptom Score
Stuffy nose · Missing
|
4 Participants
n=314 Participants
|
4 Participants
n=312 Participants
|
8 Participants
n=626 Participants
|
|
Symptom Score
Rhinorrhea · Absent
|
77 Participants
n=314 Participants
|
54 Participants
n=312 Participants
|
131 Participants
n=626 Participants
|
|
Symptom Score
Rhinorrhea · Mild
|
79 Participants
n=314 Participants
|
96 Participants
n=312 Participants
|
175 Participants
n=626 Participants
|
|
Symptom Score
Rhinorrhea · Moderate
|
96 Participants
n=314 Participants
|
84 Participants
n=312 Participants
|
180 Participants
n=626 Participants
|
|
Symptom Score
Rhinorrhea · Severe
|
56 Participants
n=314 Participants
|
74 Participants
n=312 Participants
|
130 Participants
n=626 Participants
|
|
Symptom Score
Rhinorrhea · Missing
|
6 Participants
n=314 Participants
|
4 Participants
n=312 Participants
|
10 Participants
n=626 Participants
|
|
Overall Symptom Score
|
15 units on a scale
n=314 Participants
|
15 units on a scale
n=312 Participants
|
15 units on a scale
n=626 Participants
|
|
Functional status
Vigorous activities · Limited a lot = 0
|
238 Participants
n=314 Participants
|
238 Participants
n=312 Participants
|
476 Participants
n=626 Participants
|
|
Functional status
Vigorous activities · Limited a little = 50
|
58 Participants
n=314 Participants
|
59 Participants
n=312 Participants
|
117 Participants
n=626 Participants
|
|
Functional status
Vigorous activities · Not limited at all = 100
|
14 Participants
n=314 Participants
|
12 Participants
n=312 Participants
|
26 Participants
n=626 Participants
|
|
Functional status
Vigorous activities · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Functional status
Moderate activities · Limited a lot = 0
|
167 Participants
n=314 Participants
|
171 Participants
n=312 Participants
|
338 Participants
n=626 Participants
|
|
Functional status
Moderate activities · Limited a little = 50
|
114 Participants
n=314 Participants
|
107 Participants
n=312 Participants
|
221 Participants
n=626 Participants
|
|
Functional status
Moderate activities · Not limited at all = 100
|
29 Participants
n=314 Participants
|
31 Participants
n=312 Participants
|
60 Participants
n=626 Participants
|
|
Functional status
Moderate activities · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Functional status
Lifting groceries · Limited a lot = 0
|
99 Participants
n=314 Participants
|
116 Participants
n=312 Participants
|
215 Participants
n=626 Participants
|
|
Functional status
Lifting groceries · Limited a little = 50
|
129 Participants
n=314 Participants
|
114 Participants
n=312 Participants
|
243 Participants
n=626 Participants
|
|
Functional status
Lifting groceries · Not limited at all = 100
|
82 Participants
n=314 Participants
|
79 Participants
n=312 Participants
|
161 Participants
n=626 Participants
|
|
Functional status
Lifting groceries · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Functional status
Climbing stairs · Limited a lot = 0
|
182 Participants
n=314 Participants
|
172 Participants
n=312 Participants
|
354 Participants
n=626 Participants
|
|
Functional status
Climbing stairs · Limited a little = 50
|
97 Participants
n=314 Participants
|
105 Participants
n=312 Participants
|
202 Participants
n=626 Participants
|
|
Functional status
Climbing stairs · Not limited at all = 100
|
31 Participants
n=314 Participants
|
32 Participants
n=312 Participants
|
63 Participants
n=626 Participants
|
|
Functional status
Climbing stairs · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Functional status
Climbing 1 flight · Limited a lot = 0
|
97 Participants
n=314 Participants
|
103 Participants
n=312 Participants
|
200 Participants
n=626 Participants
|
|
Functional status
Climbing 1 flight · Limited a little = 50
|
146 Participants
n=314 Participants
|
129 Participants
n=312 Participants
|
275 Participants
n=626 Participants
|
|
Functional status
Climbing 1 flight · Not limited at all = 100
|
67 Participants
n=314 Participants
|
77 Participants
n=312 Participants
|
144 Participants
n=626 Participants
|
|
Functional status
Climbing 1 flight · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Functional status
Bending or kneeling · Limited a lot = 0
|
89 Participants
n=314 Participants
|
82 Participants
n=312 Participants
|
171 Participants
n=626 Participants
|
|
Functional status
Bending or kneeling · Limited a little = 50
|
118 Participants
n=314 Participants
|
133 Participants
n=312 Participants
|
251 Participants
n=626 Participants
|
|
Functional status
Bending or kneeling · Not limited at all = 100
|
103 Participants
n=314 Participants
|
94 Participants
n=312 Participants
|
197 Participants
n=626 Participants
|
|
Functional status
Bending or kneeling · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Functional status
Walking > 1 mile · Limited a lot = 0
|
199 Participants
n=314 Participants
|
202 Participants
n=312 Participants
|
401 Participants
n=626 Participants
|
|
Functional status
Walking > 1 mile · Limited a little = 50
|
81 Participants
n=314 Participants
|
78 Participants
n=312 Participants
|
159 Participants
n=626 Participants
|
|
Functional status
Walking > 1 mile · Not limited at all = 100
|
30 Participants
n=314 Participants
|
29 Participants
n=312 Participants
|
59 Participants
n=626 Participants
|
|
Functional status
Walking > 1 mile · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Functional status
Walking blocks · Limited a lot = 0
|
169 Participants
n=314 Participants
|
177 Participants
n=312 Participants
|
346 Participants
n=626 Participants
|
|
Functional status
Walking blocks · Limited a little = 50
|
100 Participants
n=314 Participants
|
91 Participants
n=312 Participants
|
191 Participants
n=626 Participants
|
|
Functional status
Walking blocks · Not limited at all = 100
|
41 Participants
n=314 Participants
|
41 Participants
n=312 Participants
|
82 Participants
n=626 Participants
|
|
Functional status
Walking blocks · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Functional status
Walking a block · Limited a lot = 0
|
101 Participants
n=314 Participants
|
108 Participants
n=312 Participants
|
209 Participants
n=626 Participants
|
|
Functional status
Walking a block · Limited a little = 50
|
123 Participants
n=314 Participants
|
111 Participants
n=312 Participants
|
234 Participants
n=626 Participants
|
|
Functional status
Walking a block · Not limited at all = 100
|
86 Participants
n=314 Participants
|
90 Participants
n=312 Participants
|
176 Participants
n=626 Participants
|
|
Functional status
Walking a block · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Functional status
Bathing/dressing self · Limited a lot = 0
|
48 Participants
n=314 Participants
|
54 Participants
n=312 Participants
|
102 Participants
n=626 Participants
|
|
Functional status
Bathing/dressing self · Limited a little = 50
|
72 Participants
n=314 Participants
|
83 Participants
n=312 Participants
|
155 Participants
n=626 Participants
|
|
Functional status
Bathing/dressing self · Not limited at all = 100
|
190 Participants
n=314 Participants
|
172 Participants
n=312 Participants
|
362 Participants
n=626 Participants
|
|
Functional status
Bathing/dressing self · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Average Functional Status
|
35 units on a scale
n=314 Participants
|
35 units on a scale
n=312 Participants
|
35 units on a scale
n=626 Participants
|
|
Global assessment
Subject feels as good today as before flu · Yes
|
9 Participants
n=314 Participants
|
7 Participants
n=312 Participants
|
16 Participants
n=626 Participants
|
|
Global assessment
Subject feels as good today as before flu · No
|
301 Participants
n=314 Participants
|
302 Participants
n=312 Participants
|
603 Participants
n=626 Participants
|
|
Global assessment
Subject feels as good today as before flu · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Global assessment
Subject functions as well today as before flu · Yes
|
23 Participants
n=314 Participants
|
20 Participants
n=312 Participants
|
43 Participants
n=626 Participants
|
|
Global assessment
Subject functions as well today as before flu · No
|
287 Participants
n=314 Participants
|
289 Participants
n=312 Participants
|
576 Participants
n=626 Participants
|
|
Global assessment
Subject functions as well today as before flu · Missing
|
4 Participants
n=314 Participants
|
3 Participants
n=312 Participants
|
7 Participants
n=626 Participants
|
|
Complications of Influenza
Sinusitis · Yes
|
11 Participants
n=314 Participants
|
14 Participants
n=312 Participants
|
25 Participants
n=626 Participants
|
|
Complications of Influenza
Sinusitis · No
|
298 Participants
n=314 Participants
|
298 Participants
n=312 Participants
|
596 Participants
n=626 Participants
|
|
Complications of Influenza
Sinusitis · Unable to assess
|
2 Participants
n=314 Participants
|
0 Participants
n=312 Participants
|
2 Participants
n=626 Participants
|
|
Complications of Influenza
Sinusitis · Missing
|
3 Participants
n=314 Participants
|
0 Participants
n=312 Participants
|
3 Participants
n=626 Participants
|
|
Complications of Influenza
Otitis Media · Yes
|
2 Participants
n=314 Participants
|
4 Participants
n=312 Participants
|
6 Participants
n=626 Participants
|
|
Complications of Influenza
Otitis Media · No
|
307 Participants
n=314 Participants
|
308 Participants
n=312 Participants
|
615 Participants
n=626 Participants
|
|
Complications of Influenza
Otitis Media · Unable to assess
|
2 Participants
n=314 Participants
|
0 Participants
n=312 Participants
|
2 Participants
n=626 Participants
|
|
Complications of Influenza
Otitis Media · Missing
|
3 Participants
n=314 Participants
|
0 Participants
n=312 Participants
|
3 Participants
n=626 Participants
|
|
Complications of Influenza
Bronchitis/Bronchiolitis · Yes
|
8 Participants
n=314 Participants
|
14 Participants
n=312 Participants
|
22 Participants
n=626 Participants
|
|
Complications of Influenza
Bronchitis/Bronchiolitis · No
|
301 Participants
n=314 Participants
|
298 Participants
n=312 Participants
|
599 Participants
n=626 Participants
|
|
Complications of Influenza
Bronchitis/Bronchiolitis · Unable to assess
|
2 Participants
n=314 Participants
|
0 Participants
n=312 Participants
|
2 Participants
n=626 Participants
|
|
Complications of Influenza
Bronchitis/Bronchiolitis · Missing
|
3 Participants
n=314 Participants
|
0 Participants
n=312 Participants
|
3 Participants
n=626 Participants
|
|
Complications of Influenza
Pneumonia · Yes
|
5 Participants
n=314 Participants
|
9 Participants
n=312 Participants
|
14 Participants
n=626 Participants
|
|
Complications of Influenza
Pneumonia · No
|
304 Participants
n=314 Participants
|
303 Participants
n=312 Participants
|
607 Participants
n=626 Participants
|
|
Complications of Influenza
Pneumonia · Unable to assess
|
2 Participants
n=314 Participants
|
0 Participants
n=312 Participants
|
2 Participants
n=626 Participants
|
|
Complications of Influenza
Pneumonia · Missing
|
3 Participants
n=314 Participants
|
0 Participants
n=312 Participants
|
3 Participants
n=626 Participants
|
|
Complications of Influenza
Using antibiotic for other reasons · Yes
|
20 Participants
n=314 Participants
|
21 Participants
n=312 Participants
|
41 Participants
n=626 Participants
|
|
Complications of Influenza
Using antibiotic for other reasons · No
|
291 Participants
n=314 Participants
|
291 Participants
n=312 Participants
|
582 Participants
n=626 Participants
|
|
Complications of Influenza
Using antibiotic for other reasons · Unable to assess
|
0 Participants
n=314 Participants
|
0 Participants
n=312 Participants
|
0 Participants
n=626 Participants
|
|
Complications of Influenza
Using antibiotic for other reasons · Missing
|
3 Participants
n=314 Participants
|
0 Participants
n=312 Participants
|
3 Participants
n=626 Participants
|
|
Medical Conditions
>= 65 years · Yes
|
251 Participants
n=314 Participants
|
247 Participants
n=312 Participants
|
498 Participants
n=626 Participants
|
|
Medical Conditions
>= 65 years · No
|
63 Participants
n=314 Participants
|
65 Participants
n=312 Participants
|
128 Participants
n=626 Participants
|
|
Medical Conditions
Asthma · Yes
|
214 Participants
n=314 Participants
|
213 Participants
n=312 Participants
|
427 Participants
n=626 Participants
|
|
Medical Conditions
Asthma · No
|
100 Participants
n=314 Participants
|
99 Participants
n=312 Participants
|
199 Participants
n=626 Participants
|
|
Medical Conditions
Neurological condition · Yes
|
297 Participants
n=314 Participants
|
293 Participants
n=312 Participants
|
590 Participants
n=626 Participants
|
|
Medical Conditions
Neurological condition · No
|
17 Participants
n=314 Participants
|
19 Participants
n=312 Participants
|
36 Participants
n=626 Participants
|
|
Medical Conditions
Chronic Lung disease · Yes
|
297 Participants
n=314 Participants
|
291 Participants
n=312 Participants
|
588 Participants
n=626 Participants
|
|
Medical Conditions
Chronic Lung disease · No
|
17 Participants
n=314 Participants
|
21 Participants
n=312 Participants
|
38 Participants
n=626 Participants
|
|
Medical Conditions
Heart disease · Yes
|
284 Participants
n=314 Participants
|
273 Participants
n=312 Participants
|
557 Participants
n=626 Participants
|
|
Medical Conditions
Heart disease · No
|
30 Participants
n=314 Participants
|
39 Participants
n=312 Participants
|
69 Participants
n=626 Participants
|
|
Medical Conditions
Blood disorder · Yes
|
306 Participants
n=314 Participants
|
307 Participants
n=312 Participants
|
613 Participants
n=626 Participants
|
|
Medical Conditions
Blood disorder · No
|
8 Participants
n=314 Participants
|
5 Participants
n=312 Participants
|
13 Participants
n=626 Participants
|
|
Medical Conditions
Endocrine · Yes
|
227 Participants
n=314 Participants
|
224 Participants
n=312 Participants
|
451 Participants
n=626 Participants
|
|
Medical Conditions
Endocrine · No
|
87 Participants
n=314 Participants
|
88 Participants
n=312 Participants
|
175 Participants
n=626 Participants
|
|
Medical Conditions
Kidney · Yes
|
306 Participants
n=314 Participants
|
306 Participants
n=312 Participants
|
612 Participants
n=626 Participants
|
|
Medical Conditions
Kidney · No
|
8 Participants
n=314 Participants
|
6 Participants
n=312 Participants
|
14 Participants
n=626 Participants
|
|
Medical Conditions
Liver disorder · Yes
|
311 Participants
n=314 Participants
|
305 Participants
n=312 Participants
|
616 Participants
n=626 Participants
|
|
Medical Conditions
Liver disorder · No
|
3 Participants
n=314 Participants
|
7 Participants
n=312 Participants
|
10 Participants
n=626 Participants
|
|
Medical Conditions
Metabolic · Yes
|
302 Participants
n=314 Participants
|
304 Participants
n=312 Participants
|
606 Participants
n=626 Participants
|
|
Medical Conditions
Metabolic · No
|
12 Participants
n=314 Participants
|
8 Participants
n=312 Participants
|
20 Participants
n=626 Participants
|
|
Medical Conditions
Weakened immune system · Yes
|
270 Participants
n=314 Participants
|
266 Participants
n=312 Participants
|
536 Participants
n=626 Participants
|
|
Medical Conditions
Weakened immune system · No
|
44 Participants
n=314 Participants
|
46 Participants
n=312 Participants
|
90 Participants
n=626 Participants
|
|
Medical Conditions
BMI >= 40 · Yes
|
240 Participants
n=314 Participants
|
261 Participants
n=312 Participants
|
501 Participants
n=626 Participants
|
|
Medical Conditions
BMI >= 40 · No
|
74 Participants
n=314 Participants
|
51 Participants
n=312 Participants
|
125 Participants
n=626 Participants
|
PRIMARY outcome
Timeframe: At Day 3Population: The population analyzed was restricted to the 407 participants who had a confirmed positive test for influenza by qPCR in the central laboratory testing and were not in the pilot study for IRC003. 13 participants (5 in the Combination Therapy and 8 in the Oseltamivir Monotherapy) had missing endpoint samples so were excluded from the analysis.
The central laboratory performed a qualitative PCR test on the NP sample from Day 0 in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.
Outcome measures
| Measure |
Combination Therapy
n=200 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=194 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs
|
40 percentage of participants analyzed
|
50 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: At Day 0, 3 and 7.Population: The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.
Number of participants who had undetectable values (less than the limit of detection \[LOD\]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ
Outcome measures
| Measure |
Combination Therapy
n=230 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=224 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Number of Participants by Virus Detection Status
Day 0 · >=LLOQ
|
221 Participants
|
200 Participants
|
|
Number of Participants by Virus Detection Status
Day 0 · >=LOD, <LLOQ
|
4 Participants
|
9 Participants
|
|
Number of Participants by Virus Detection Status
Day 0 · <LOD
|
5 Participants
|
15 Participants
|
|
Number of Participants by Virus Detection Status
Day 0 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants by Virus Detection Status
Day 3 · >=LLOQ
|
65 Participants
|
87 Participants
|
|
Number of Participants by Virus Detection Status
Day 3 · >=LOD, <LLOQ
|
22 Participants
|
25 Participants
|
|
Number of Participants by Virus Detection Status
Day 3 · <LOD
|
134 Participants
|
104 Participants
|
|
Number of Participants by Virus Detection Status
Day 3 · Missing
|
9 Participants
|
8 Participants
|
|
Number of Participants by Virus Detection Status
Day 7 · >=LLOQ
|
19 Participants
|
24 Participants
|
|
Number of Participants by Virus Detection Status
Day 7 · >=LOD, <LLOQ
|
4 Participants
|
7 Participants
|
|
Number of Participants by Virus Detection Status
Day 7 · <LOD
|
193 Participants
|
184 Participants
|
|
Number of Participants by Virus Detection Status
Day 7 · Missing
|
14 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: At Day 0, 3 and 7Population: The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.
Median, 25% and 75% percentile of the value of viral shedding (Results \<LOD were imputed as the LOD value, and Results \>= LOD, \<LLOQ were imputed as the LLOQ value.)
Outcome measures
| Measure |
Combination Therapy
n=230 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=224 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
qPCR Viral Shedding
Day 0
|
6.4 Log10 copies/mL
Interval 5.6 to 7.2
|
6.7 Log10 copies/mL
Interval 5.1 to 7.7
|
|
qPCR Viral Shedding
Day 3
|
3.4 Log10 copies/mL
Interval 3.2 to 4.2
|
3.9 Log10 copies/mL
Interval 3.2 to 4.95
|
|
qPCR Viral Shedding
Day 7
|
3.2 Log10 copies/mL
Interval 3.2 to 3.4
|
3.2 Log10 copies/mL
Interval 3.2 to 3.4
|
SECONDARY outcome
Timeframe: At day 3 and 7.Population: The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.
Number of participants with undetectable viral load at both Day 3 and Day 7; detectable at Day 3 and undetectable at Day 7; detectable at Day 7 (irrespective of whether or not detectable at Day 3).
Outcome measures
| Measure |
Combination Therapy
n=230 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=224 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Number of Participants Shedding Virus
Undetectable at both Day 3 and 7
|
126 Participants
|
95 Participants
|
|
Number of Participants Shedding Virus
Detectable at Day 3 and undetectable at Day 7
|
67 Participants
|
88 Participants
|
|
Number of Participants Shedding Virus
Detectable at Day 7
|
23 Participants
|
30 Participants
|
|
Number of Participants Shedding Virus
Missing result at Day 3 and/or Day 7
|
14 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Duration of clinical symptoms is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1 (mild). A measurement is considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements are obtained per day) and then the daily assessment thereafter. Time will then be calculated in half-days through to Day 7. If a subject's first two assessments on (baseline assessment and first subsequent diary card assessment) satisfy this criterion, then the duration will be set to zero. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms evaluated.
Outcome measures
| Measure |
Combination Therapy
n=314 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Time to Alleviation of Influenza Clinical Symptoms.
|
4.5 Days
Interval 4.0 to 5.0
|
4.0 Days
Interval 3.5 to 4.5
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Otherwise, fever was considered not present during the period since the diary card was previously completed, except that the evaluation was considered missing if either the temperature or the antipyretic drug use entry was not completed on the diary card. The duration of fever was defined as the time from Day 0 to the first of two successive assessments (through to Day 7) or to the first assessment (Day 8 onwards) at which no fever was present according to this definition.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with fever evaluated.
Outcome measures
| Measure |
Combination Therapy
n=314 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Time to Absence of Fever
|
0.5 Days
Not estimable
|
0.5 Days
Not estimable
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which includes all participants who were randomized properly and who had received at least one dose of study drug.
The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Time to resolution of all clinical symptoms and fever is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1(mild) and no fever \>=38.0 C or antipyretic drug is reported. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms and fever evaluated.
Outcome measures
| Measure |
Combination Therapy
n=314 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Time to Resolution of All Symptoms AND Fever
|
4.5 Days
Interval 4.0 to 5.0
|
4.5 Days
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
Time to feeling as good as before influenza is defined as time to the first of two successive 'yes' responses to the question of 'feeling as good as you did before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.
Outcome measures
| Measure |
Combination Therapy
n=314 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Time to Feeling as Good as Before the Onset of the Influenza Illness
|
7.5 Days
Interval 7.0 to 7.5
|
6.5 Days
Interval 6.0 to 7.0
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
Time to return to pre-influenza function is defined as the time from Day 0 to the first of two successive 'Yes' answers to the global assessment question 'Are you functioning as well as you were before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.
Outcome measures
| Measure |
Combination Therapy
n=314 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Time to Return to Pre-influenza Function
|
7.0 Days
Interval 6.0 to 7.5
|
6.0 Days
Interval 5.0 to 6.5
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
Time to return of physical function to pre-illness level was defined as the time from Day 0 to the first of two successive measurements at which the physical function score equals or is better than the pre-illness score (obtained by recall at enrollment).For subjects who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with physical function evaluated.
Outcome measures
| Measure |
Combination Therapy
n=314 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Time to Return of Physical Function to Pre-illness Leve
|
7.0 Days
Interval 6.0 to 8.0
|
6.0 Days
Interval 6.0 to 7.0
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
Clinical failure at Day 5 is defined as the need for continued (non-study) antiviral use after Day 5.
Outcome measures
| Measure |
Combination Therapy
n=314 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Percentage of Participants With Clinical Failure at Day 5
|
7.0 percentage of participants analyzed
|
7.7 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug. The categories in the table are not mutually exclusive (because some participants had multiple complications) and the last row of the table summarizes all incidents.
Participants were assessed for the signs/symptoms suggestive of one of the following complications: Sinusitis, Otitis Media ,Bronchitis / Bronchiolitis, Pneumonia and antibiotic use for reason other than above.
Outcome measures
| Measure |
Combination Therapy
n=314 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.
Bronchitis Bronchiolitis
|
5.7 percentage of participants analyzed
|
3.5 percentage of participants analyzed
|
|
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.
Sinustis
|
4.5 percentage of participants analyzed
|
4.5 percentage of participants analyzed
|
|
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.
Otitis Media
|
0.3 percentage of participants analyzed
|
1.0 percentage of participants analyzed
|
|
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.
Pneumonia
|
2.2 percentage of participants analyzed
|
1.9 percentage of participants analyzed
|
|
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.
Antibiotic use for other reasons
|
8.6 percentage of participants analyzed
|
9.3 percentage of participants analyzed
|
|
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.
At least one complication and/or use of antibiotic
|
16.6 percentage of participants analyzed
|
15.4 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
Percentage of participants who required new or increased use of supplemental oxygen
Outcome measures
| Measure |
Combination Therapy
n=314 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Percentage of Participants Who Required New or Increased Use of Supplemental Oxygen
|
1.91 percentage of participants analyzed
|
1.6 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
The percentage of participants hospitalized by 28 days was estimated from the Kaplan-Meier curves.
Outcome measures
| Measure |
Combination Therapy
n=314 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Percentage of Participants Who Required Hospitalization.
|
4.28 percentage of participants analyzed
Interval 2.0 to 6.56
|
0.98 percentage of participants analyzed
Interval -0.12 to 2.08
|
SECONDARY outcome
Timeframe: From treatment initiation to Day 28Population: The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
Number of deaths
Outcome measures
| Measure |
Combination Therapy
n=314 Participants
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 Participants
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
28-day Mortality
|
0 participants
|
1 participants
|
Adverse Events
Combination Therapy
Serious events: 14 serious events
Other events: 148 other events
Deaths: 0 deaths
Oseltamivir Monotherapy
Serious events: 6 serious events
Other events: 163 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Combination Therapy
n=314 participants at risk
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 participants at risk
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.32%
1/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Cardiac disorders
Atrial tachycardia
|
0.32%
1/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.32%
1/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.64%
2/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.32%
1/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Gastrointestinal disorders
Nausea
|
0.32%
1/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Infections and infestations
Cellulitis
|
0.32%
1/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Infections and infestations
Gastroenteritis
|
0.32%
1/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Infections and infestations
Pneumonia
|
0.32%
1/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.32%
1/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.32%
1/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.32%
1/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.32%
1/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.32%
1/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.64%
2/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.32%
1/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.32%
1/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.32%
1/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.32%
1/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
0.00%
0/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
Other adverse events
| Measure |
Combination Therapy
n=314 participants at risk
Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
|
Oseltamivir Monotherapy
n=312 participants at risk
Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.7%
40/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
16.7%
52/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Gastrointestinal disorders
Nausea
|
16.6%
52/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
16.0%
50/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Gastrointestinal disorders
Vomiting
|
10.8%
34/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
7.1%
22/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
General disorders
Fatigue
|
5.7%
18/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
3.8%
12/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
General disorders
Pyrexia
|
5.1%
16/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
5.8%
18/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
17/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
4.2%
13/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Nervous system disorders
Dizziness
|
7.3%
23/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
7.1%
22/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Nervous system disorders
Headache
|
4.5%
14/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
6.1%
19/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
14/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
7.1%
22/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
15/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
3.5%
11/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.1%
13/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
5.4%
17/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
|
Vascular disorders
Hypertension
|
3.8%
12/314 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
4.8%
15/312 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.
|
Additional Information
John Beigel, M.D.
Leidos Biomedical Research, Inc. is support to the National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 301-451-9881
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place