Pain, Postoperative
Conditions
Keywords
safety, diclofenac, pain, postoperative
Brief summary
This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.
Detailed description
This is an open-label, multiple-dose, multiple-day, single-arm safety study of repeat-doses of DIC075V in patients with acute post-operative pain following abdominal (i.e., non-laparoscopic abdominal surgeries) or orthopedic (e.g., hip or knee joint replacement) surgery. Eligible patients will receive DIC075V IV bolus q6 hours. Safety assessments will be collected at baseline (immediately prior to starting DIC075V therapy) and at study discharge or early termination.
Interventions
DRUGDIC075V (intravenous diclofenac sodium)
multiple doses up to 5 days
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* abdominal ( non-laparoscopic abdominal surgeries) or orthopedic ( hip or knee joint replacement) surgery or other surgeries requiring multiple doses of parenterally administered NSAIDs over multiple days * Expected stay \> 48 hrs
Exclusion criteria
* bilirubin \> 2.5 mg/dl * prothrombin time is \> 20% above the upper limit of normal * serum creatinine is \> 1.9 mg/dl at screening. * known allergy or hypersensitivity to diclofenac, other NSAIDs,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included SAEs and all non-SAEs that occurred during the study. |
| Number of Participants Who Took at Least 1 Concomitant Medication | Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days) | Concomitant medications were medications that were taken concurrently on or after first dose of study drug. |
| Number of Participants With Abnormal Urinalysis Findings | Baseline (Day 1, immediately before dosing) up to study discharge/early termination (maximum up to Day 5) | Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator. |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline | Baseline (Day 1, immediately before dosing) | 12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion. |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination | Study discharge/early termination (maximum up to Day 5) | 12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion. |
| Change From Baseline in Blood Pressure at Study Discharge/Early Termination | Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days) | Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) in millimeter of mercury (mmHg) was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes. |
| Change From Baseline in Blood Pressure at Clinic Follow-up Visit | Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days) | Change from baseline in SBP and DBP in mmHg was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes. |
| Change From Baseline in Respiratory Rate at Study Discharge/Early Termination | Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days) | Respiratory rate was measured after the participant had taken rest for 5 minutes. |
| Change From Baseline in Respiratory Rate at Clinic Follow-up Visit | Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days) | Respiratory rate was measured after the participant had taken rest for 5 minutes. |
| Change From Baseline in Heart Rate at Study Discharge/Early Termination | Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days) | Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes. |
| Change From Baseline in Heart Rate at Clinic Follow-up Visit | Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days) | Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes. |
| Number of Participants With Wound Assessment at Study Discharge/Early Termination | Study discharge/early termination (maximum up to Day 5) | Wound assessment had 6 questions, completed by investigator/sub-investigator. Question related to extent of healing; extent and degree of inflammation and extent of drainage had options: much better than expected, better than expected, normal, slower than expected, and much slower than expected. Question related to separation of surgical incision had options: no separation, barely detectible separation, localized separation, mostly separated, and complete separation (dehiscence). Question related to infection at surgical site had options: definitely, no infection, possibly infected, probably infected, certainly infected, and abscess/gross cellulitis. Question related to prescription of postoperative systemic antibiotics had options: no, yes for prophylaxis, and yes for infection. Every question there was category Not Done for participants with no wound assessment other than the reason 'missing' and category Missing, where participants were missing for wound assessment. |
| Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline | Baseline (Day 1, immediately before dosing) | Thrombophlebitis assessment evaluation was done using following grades: 0 equals to (=) no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection. |
| Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination | Study discharge/early termination (maximum up to Day 5) | Thrombophlebitis assessment evaluation was done using following grades: 0= no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection. |
| Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | Screening (0 to 21 days prior to surgery) | Physical examination included the assessment of general appearance, skin; head, ears, eyes, nose, and throat (HEENT); neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion. |
| Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days) | Physical examination included the assessment of general appearance, skin; HEENT; neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion. |
Countries
United States
Participant flow
Recruitment details
Participants with immediate acute postoperative pain, who were stable according to the study site's usual practice, were enrolled in the study. They received intravenous (IV) diclofenac sodium (DIC075V) bolus as their primary postoperative analgesic.
Pre-assignment details
Total 1171 participants signed the inform consent form (ICF). Out of which 121 participants were screen failure and 1050 actually enrolled into the study and 971 assigned to study treatment.
Participants by arm
| Arm | Count |
|---|---|
| DIC075V Participants weighing \>=95 kg received DIC075V 50 mg IV bolus once every 6 hours. Participants with more than 1 NSAIDS related risk factor, example, weighing \<95 kg along with mild renal insufficiency received DIC075V 37.5 mg IV bolus once every 6 hours. Participants received DIC075V for a minimum of 8 consecutive doses and until they were completely transitioned to oral analgesics, discharged from the institution, received a maximum of 5 days of treatment with DIC075V, or discontinued from the study, whichever occurred first. Participants returned to the clinic for a safety follow-up visit 4-10 days after their last dose of DIC075V and completed a safety follow-up telephone call 30-37 days post-last dose of DIC075V. | 971 |
| Total | 971 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Enrolled, Not Treated | 79 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Other | 5 |
| Overall Study | Participants Non-compliant With Study Procedures | 5 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | DIC075V |
|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 13.4 |
| Sex: Female, Male Female | 617 Participants |
| Sex: Female, Male Male | 354 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 816 / 971 |
| serious Total, serious adverse events | 73 / 971 |
Outcome results
Primary
Change From Baseline in Blood Pressure at Clinic Follow-up Visit
Change from baseline in SBP and DBP in mmHg was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.
Time frame: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DIC075V | Change From Baseline in Blood Pressure at Clinic Follow-up Visit | SBP | 0.2 mmHg | Standard Deviation 21.4 |
| DIC075V | Change From Baseline in Blood Pressure at Clinic Follow-up Visit | DBP | 4.4 mmHg | Standard Deviation 13.9 |
Primary
Change From Baseline in Blood Pressure at Study Discharge/Early Termination
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) in millimeter of mercury (mmHg) was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.
Time frame: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DIC075V | Change From Baseline in Blood Pressure at Study Discharge/Early Termination | SBP | -2.2 mmHg | Standard Deviation 21.5 |
| DIC075V | Change From Baseline in Blood Pressure at Study Discharge/Early Termination | DBP | -0.5 mmHg | Standard Deviation 14.7 |
Primary
Change From Baseline in Heart Rate at Clinic Follow-up Visit
Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.
Time frame: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIC075V | Change From Baseline in Heart Rate at Clinic Follow-up Visit | 2.4 Beats per minute | Standard Deviation 15.5 |
Primary
Change From Baseline in Heart Rate at Study Discharge/Early Termination
Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.
Time frame: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIC075V | Change From Baseline in Heart Rate at Study Discharge/Early Termination | 3.8 Beats per minute | Standard Deviation 15.4 |
Primary
Change From Baseline in Respiratory Rate at Clinic Follow-up Visit
Respiratory rate was measured after the participant had taken rest for 5 minutes.
Time frame: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIC075V | Change From Baseline in Respiratory Rate at Clinic Follow-up Visit | 1.0 Breaths per minute | Standard Deviation 3.8 |
Primary
Change From Baseline in Respiratory Rate at Study Discharge/Early Termination
Respiratory rate was measured after the participant had taken rest for 5 minutes.
Time frame: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIC075V | Change From Baseline in Respiratory Rate at Study Discharge/Early Termination | 1.3 Breaths per minute | Standard Deviation 3 |
Primary
Number of Participants Who Took at Least 1 Concomitant Medication
Concomitant medications were medications that were taken concurrently on or after first dose of study drug.
Time frame: Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DIC075V | Number of Participants Who Took at Least 1 Concomitant Medication | 971 Participants |
Primary
Number of Participants With Abnormal Urinalysis Findings
Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator.
Time frame: Baseline (Day 1, immediately before dosing) up to study discharge/early termination (maximum up to Day 5)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DIC075V | Number of Participants With Abnormal Urinalysis Findings | 2 Participants |
Primary
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline
12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
Time frame: Baseline (Day 1, immediately before dosing)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DIC075V | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline | 14 Participants |
Primary
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination
12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
Time frame: Study discharge/early termination (maximum up to Day 5)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DIC075V | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination | 13 Participants |
Primary
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit
Physical examination included the assessment of general appearance, skin; HEENT; neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.
Time frame: Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
Population: Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | General appearance | 8 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | Skin | 13 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | HEENT | 2 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | Lymph Nodes | 0 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | Cardiovascular | 5 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | Neck/Thyroid | 1 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | Oral Cavity | 0 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | Lungs | 5 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | Breasts | 0 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | Abdomen | 12 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | Genitourinary | 1 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | Neurologic | 5 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit | Joints/Extremities | 41 Participants |
Primary
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening
Physical examination included the assessment of general appearance, skin; head, ears, eyes, nose, and throat (HEENT); neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.
Time frame: Screening (0 to 21 days prior to surgery)
Population: Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | Breasts | 0 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | Abdomen | 29 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | Genitourinary | 32 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | Neurologic | 10 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | Joints/Extremities | 295 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | General Appearance | 8 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | Skin | 3 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | HEENT | 7 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | Neck/Thyroid | 1 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | Oral Cavity | 2 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | Lymph Nodes | 0 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | Cardiovascular | 3 Participants |
| DIC075V | Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening | Lungs | 0 Participants |
Primary
Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline
Thrombophlebitis assessment evaluation was done using following grades: 0 equals to (=) no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.
Time frame: Baseline (Day 1, immediately before dosing)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DIC075V | Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline | Grade 0 | 960 Participants |
| DIC075V | Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline | Grade 1 | 3 Participants |
| DIC075V | Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline | Grade 2 | 0 Participants |
| DIC075V | Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline | Grade 3 | 0 Participants |
| DIC075V | Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline | Grade 4 | 0 Participants |
| DIC075V | Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline | Grade 5 | 0 Participants |
Primary
Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination
Thrombophlebitis assessment evaluation was done using following grades: 0= no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.
Time frame: Study discharge/early termination (maximum up to Day 5)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DIC075V | Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination | Grade 4 | 0 Participants |
| DIC075V | Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination | Grade 5 | 0 Participants |
| DIC075V | Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination | Grade 0 | 925 Participants |
| DIC075V | Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination | Grade 1 | 26 Participants |
| DIC075V | Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination | Grade 2 | 3 Participants |
| DIC075V | Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination | Grade 3 | 3 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included SAEs and all non-SAEs that occurred during the study.
Time frame: Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DIC075V | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 823 Participants |
| DIC075V | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 73 Participants |
Primary
Number of Participants With Wound Assessment at Study Discharge/Early Termination
Wound assessment had 6 questions, completed by investigator/sub-investigator. Question related to extent of healing; extent and degree of inflammation and extent of drainage had options: much better than expected, better than expected, normal, slower than expected, and much slower than expected. Question related to separation of surgical incision had options: no separation, barely detectible separation, localized separation, mostly separated, and complete separation (dehiscence). Question related to infection at surgical site had options: definitely, no infection, possibly infected, probably infected, certainly infected, and abscess/gross cellulitis. Question related to prescription of postoperative systemic antibiotics had options: no, yes for prophylaxis, and yes for infection. Every question there was category Not Done for participants with no wound assessment other than the reason 'missing' and category Missing, where participants were missing for wound assessment.
Time frame: Study discharge/early termination (maximum up to Day 5)
Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of healing: Normal | 727 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent and degree of Inflammation: Normal | 657 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent and degree of Inflammation: Slower than expected | 11 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent and degree of Inflammation: Much slower than expected | 0 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent and degree of inflammation: Not done | 33 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of drainage: Much better than expected | 78 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Separation of incision: Complete separation | 0 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Separation of incision: Not done | 33 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Postoperative systemic antibiotics: Not done | 33 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Separation of incision: Localized separation | 35 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Separation of incision: Mostly separated | 0 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Separation of incision: Missing | 7 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Infection at surgical site: Definitely, No infection | 921 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Infection at surgical site: Possibly infected | 12 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Infection at surgical site: Probably infected | 1 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Infection at surgical site: Certainly infected | 1 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Infection at surgical site: Abscess or gross cellulitis | 0 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Infection at surgical site: Not done | 33 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Infection at surgical site: Missing | 3 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Postoperative systemic antibiotics: No | 673 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Postoperative systemic antibiotics: Yes, for prophylaxis | 262 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Postoperative systemic antibiotics: Yes, for infection | 1 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Postoperative systemic antibiotics: Missing | 2 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of healing: Much better than expected | 40 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of healing: Better than expected | 154 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of healing: Slower than expected | 11 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of healing: Much slower than expected | 0 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of healing: Not done | 33 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of healing: Missing | 6 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent and degree of Inflammation: Much better than expected | 50 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent and degree of inflammation: Better than expected | 214 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent and degree of inflammation: Missing | 6 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of drainage: Better than expected | 195 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of drainage: Normal | 633 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of drainage: Slower than expected | 29 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of drainage: Much slower than expected | 1 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of drainage: Not done | 33 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Extent of drainage: Missing | 2 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Separation of Incision: No separation | 809 Participants |
| DIC075V | Number of Participants With Wound Assessment at Study Discharge/Early Termination | Separation of Incision: Barely detectable separation | 87 Participants |