Trial Outcomes & Findings for An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain (NCT NCT00726388)

Last Updated: 2021-10-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1050 participants

Primary outcome timeframe

Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)

Results posted on

2021-10-13

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	DIC075V Participants weighing greater than or equal to (\>=) 95 kg received DIC075V 50 milligram (mg) IV bolus once every 6 hours. Participants with more than 1 non-steroidal anti-inflammatory drug (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.
Overall Study STARTED	1050
Overall Study Treated	971
Overall Study COMPLETED	943
Overall Study NOT COMPLETED	107

Reasons for withdrawal

Reasons for withdrawal
Measure	DIC075V Participants weighing greater than or equal to (\>=) 95 kg received DIC075V 50 milligram (mg) IV bolus once every 6 hours. Participants with more than 1 non-steroidal anti-inflammatory drug (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.
Overall Study Withdrawal by Subject	5
Overall Study Adverse Event	3
Overall Study Lost to Follow-up	10
Overall Study Participants Non-compliant With Study Procedures	5
Overall Study Other	5
Overall Study Enrolled, Not Treated	79

Baseline Characteristics

An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DIC075V n=971 Participants 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.
Age, Continuous	58.8 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	617 Participants n=5 Participants
Sex: Female, Male Male	354 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DIC075V n=971 Participants 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	823 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	73 Participants

PRIMARY outcome

Timeframe: 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.

Concomitant medications were medications that were taken concurrently on or after first dose of study drug.

Outcome measures

Outcome measures
Measure	DIC075V n=971 Participants 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.
Number of Participants Who Took at Least 1 Concomitant Medication	971 Participants

PRIMARY outcome

Timeframe: 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.

Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator.

Outcome measures

Outcome measures
Measure	DIC075V n=971 Participants 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.
Number of Participants With Abnormal Urinalysis Findings	2 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1, immediately before dosing)

Population: Safety population included all participants who received DIC075V and had at least 1 safety assessment.

12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.

Outcome measures

Outcome measures
Measure	DIC075V n=971 Participants 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.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline	14 Participants

PRIMARY outcome

Timeframe: 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.

12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.

Outcome measures

Outcome measures
Measure	DIC075V n=971 Participants 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.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination	13 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	DIC075V n=958 Participants 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.
Change From Baseline in Blood Pressure at Study Discharge/Early Termination SBP	-2.2 mmHg Standard Deviation 21.5
Change From Baseline in Blood Pressure at Study Discharge/Early Termination DBP	-0.5 mmHg Standard Deviation 14.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DIC075V n=941 Participants 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.
Change From Baseline in Blood Pressure at Clinic Follow-up Visit SBP	0.2 mmHg Standard Deviation 21.4
Change From Baseline in Blood Pressure at Clinic Follow-up Visit DBP	4.4 mmHg Standard Deviation 13.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DIC075V n=957 Participants 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.
Change From Baseline in Respiratory Rate at Study Discharge/Early Termination	1.3 Breaths per minute Standard Deviation 3.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DIC075V n=937 Participants 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.
Change From Baseline in Respiratory Rate at Clinic Follow-up Visit	1.0 Breaths per minute Standard Deviation 3.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DIC075V n=958 Participants 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.
Change From Baseline in Heart Rate at Study Discharge/Early Termination	3.8 Beats per minute Standard Deviation 15.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DIC075V n=939 Participants 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.
Change From Baseline in Heart Rate at Clinic Follow-up Visit	2.4 Beats per minute Standard Deviation 15.5

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	DIC075V n=971 Participants 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.
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of healing: Much better than expected	40 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of healing: Better than expected	154 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of healing: Normal	727 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of healing: Slower than expected	11 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of healing: Much slower than expected	0 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of healing: Not done	33 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of healing: Missing	6 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent and degree of Inflammation: Much better than expected	50 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent and degree of inflammation: Better than expected	214 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent and degree of Inflammation: Normal	657 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent and degree of Inflammation: Slower than expected	11 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent and degree of Inflammation: Much slower than expected	0 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent and degree of inflammation: Not done	33 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent and degree of inflammation: Missing	6 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of drainage: Much better than expected	78 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of drainage: Better than expected	195 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of drainage: Normal	633 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of drainage: Slower than expected	29 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of drainage: Much slower than expected	1 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of drainage: Not done	33 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Extent of drainage: Missing	2 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Separation of Incision: No separation	809 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Separation of Incision: Barely detectable separation	87 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Separation of incision: Localized separation	35 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Separation of incision: Mostly separated	0 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Separation of incision: Complete separation	0 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Separation of incision: Not done	33 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Separation of incision: Missing	7 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Infection at surgical site: Definitely, No infection	921 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Infection at surgical site: Possibly infected	12 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Infection at surgical site: Probably infected	1 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Infection at surgical site: Certainly infected	1 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Infection at surgical site: Abscess or gross cellulitis	0 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Infection at surgical site: Not done	33 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Infection at surgical site: Missing	3 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Postoperative systemic antibiotics: No	673 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Postoperative systemic antibiotics: Yes, for prophylaxis	262 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Postoperative systemic antibiotics: Yes, for infection	1 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Postoperative systemic antibiotics: Not done	33 Participants
Number of Participants With Wound Assessment at Study Discharge/Early Termination Postoperative systemic antibiotics: Missing	2 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DIC075V n=963 Participants 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.
Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline Grade 0	960 Participants
Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline Grade 1	3 Participants
Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline Grade 2	0 Participants
Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline Grade 3	0 Participants
Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline Grade 4	0 Participants
Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline Grade 5	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DIC075V n=957 Participants 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.
Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination Grade 0	925 Participants
Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination Grade 1	26 Participants
Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination Grade 2	3 Participants
Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination Grade 3	3 Participants
Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination Grade 4	0 Participants
Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination Grade 5	0 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	DIC075V n=971 Participants 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.
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening Abdomen	29 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening Genitourinary	32 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening Neurologic	10 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening Joints/Extremities	295 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening General Appearance	8 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening Skin	3 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening HEENT	7 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening Neck/Thyroid	1 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening Oral Cavity	2 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening Lymph Nodes	0 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening Cardiovascular	3 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening Lungs	0 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening Breasts	0 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	DIC075V n=971 Participants 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.
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit General appearance	8 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit Skin	13 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit HEENT	2 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit Neck/Thyroid	1 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit Oral Cavity	0 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit Lymph Nodes	0 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit Cardiovascular	5 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit Lungs	5 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit Breasts	0 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit Abdomen	12 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit Genitourinary	1 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit Neurologic	5 Participants
Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit Joints/Extremities	41 Participants

Adverse Events

DIC075V

Serious events: 73 serious events

Other events: 816 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DIC075V n=971 participants at risk 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.
Cardiac disorders ATRIAL FIBRILLATION	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders NAUSEA	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders VOMITING	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders ABDOMINAL PAIN	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders ANAL HAEMORRHAGE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders CONSTIPATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders ENTEROCUTANEOUS FISTULA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders HAEMATOCHEZIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders INTESTINAL PERFORATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders PANCREATITIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders PERITONITIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders PYREXIA	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders NON-CARDIAC CHEST PAIN	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders OEDEMA PERIPHERAL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations INCISION SITE CELLULITIS	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations WOUND INFECTION	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations CELLULITIS	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations POSTOPERATIVE WOUND INFECTION	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations SEPSIS	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations ABDOMINAL WALL ABSCESS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations BRONCHITIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations CATHETER SEPSIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations HAEMATOMA INFECTION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations INCISION SITE ABSCESS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations INCISION SITE INFECTION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations LOBAR PNEUMONIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations PELVIC ABSCESS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations POST PROCEDURAL CELLULITIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations VAGINAL CELLULITIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations WOUND ABSCESS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations WOUND INFECTION STAPHYLOCOCCAL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.51% 5/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications ANASTOMOTIC HAEMORRHAGE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications ANASTOMOTIC LEAK	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications CONTUSION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications INCISION SITE HAEMATOMA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications INCISION SITE PAIN	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications POST PROCEDURAL DISCHARGE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications POSTOPERATIVE ILEUS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications POSTOPERATIVE WOUND COMPLICATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications TENDON RUPTURE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD CREATININE INCREASED	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD CULTURE POSITIVE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations ELECTROCARDIOGRAM QT PROLONGED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations LIVER FUNCTION TEST ABNORMAL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders DEHYDRATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN SMALL INTESTINAL NEOPLASM	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders SEDATION	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders MENTAL STATUS CHANGES	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders RENAL FAILURE ACUTE	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders RENAL FAILURE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders RENAL TUBULAR NECROSIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.62% 6/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders ASPIRATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders RESPIRATORY ARREST	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders ANGIOEDEMA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Vascular disorders HYPOTENSION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations BACTERAEMIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.

Other adverse events

Other adverse events
Measure	DIC075V n=971 participants at risk 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.
Blood and lymphatic system disorders ANAEMIA	0.82% 8/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Blood and lymphatic system disorders THROMBOCYTOPENIA	1.1% 11/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Blood and lymphatic system disorders LEUKOCYTOSIS	1.1% 11/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Blood and lymphatic system disorders HAEMORRHAGIC ANAEMIA	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Blood and lymphatic system disorders COAGULOPATHY	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Blood and lymphatic system disorders THROMBOCYTHAEMIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders BRADYCARDIA	1.0% 10/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders ATRIAL FIBRILLATION	0.62% 6/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders TACHYCARDIA	3.3% 32/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders SINUS TACHYCARDIA	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders SINUS BRADYCARDIA	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders ANGINA PECTORIS	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders ARRHYTHMIA	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders CARDIOMEGALY	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders MYOCARDIAL INFARCTION	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders SUPRAVENTRICULAR EXTRASYSTOLES	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders ARTERIOSCLEROSIS CORONARY ARTERY	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders BUNDLE BRANCH BLOCK LEFT	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders BUNDLE BRANCH BLOCK RIGHT	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders PALPITATIONS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders PERICARDIAL EFFUSION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Cardiac disorders RIGHT VENTRICULAR HYPERTROPHY	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Ear and labyrinth disorders TINNITUS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Endocrine disorders GOITRE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Eye disorders CONJUNCTIVITIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Eye disorders DRY EYE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Eye disorders EYE IRRITATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Eye disorders EYE PAIN	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Eye disorders EYELID DISORDER	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Eye disorders VISION BLURRED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders NAUSEA	37.0% 359/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders CONSTIPATION	18.6% 181/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders VOMITING	8.3% 81/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders FLATULENCE	3.9% 38/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders DYSPEPSIA	3.7% 36/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders DIARRHOEA	2.9% 28/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders ABDOMINAL DISTENSION	1.6% 16/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders DRY MOUTH	1.1% 11/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders ABDOMINAL PAIN	0.72% 7/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.51% 5/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders HAEMATOCHEZIA	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders STOMACH DISCOMFORT	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders GASTRITIS	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders HAEMORRHOIDS	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders LIP DRY	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders RETCHING	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders ABDOMINAL TENDERNESS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders ANAL ULCER	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders ASCITES	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders COLONIC POLYP	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders EPIGASTRIC DISCOMFORT	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders ERUCTATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders GASTROINTESTINAL PAIN	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders HAEMATEMESIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders ILEUS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders ILEUS PARALYTIC	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders LIP ULCERATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders PARAESTHESIA ORAL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders RECTAL DISCHARGE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders SWOLLEN TONGUE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders TONGUE BLISTERING	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders TONGUE DISORDER	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Gastrointestinal disorders TOOTHACHE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders PYREXIA	5.8% 56/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INFUSION SITE PAIN	5.1% 50/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders OEDEMA PERIPHERAL	3.8% 37/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders ASTHENIA	2.6% 25/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INFUSION SITE EXTRAVASATION	1.4% 14/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders CHILLS	1.2% 12/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders HYPOTHERMIA	1.2% 12/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INFUSION SITE THROMBOSIS	0.62% 6/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders FATIGUE	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders GENERALISED OEDEMA	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INFUSION SITE ERYTHEMA	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INFUSION SITE SWELLING	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders BREAKTHROUGH PAIN	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders CHEST PAIN	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INFUSION SITE OEDEMA	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders CHEST DISCOMFORT	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INFUSION SITE IRRITATION	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders OEDEMA	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders ADVERSE DRUG REACTION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders APPLICATION SITE VESICLES	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders EARLY SATIETY	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders FACE OEDEMA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders FEELING HOT	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders IMPAIRED HEALING	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INFUSION SITE BRUISING	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INFUSION SITE HAEMATOMA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INFUSION SITE HAEMORRHAGE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INFUSION SITE PARAESTHESIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INFUSION SITE WARMTH	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INJECTION SITE HAEMORRHAGE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INJECTION SITE PAIN	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders INJECTION SITE SWELLING	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders PAIN	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders PITTING OEDEMA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
General disorders THIRST	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Hepatobiliary disorders CHOLELITHIASIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations URINARY TRACT INFECTION	2.1% 20/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations WOUND INFECTION	0.93% 9/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations POSTOPERATIVE WOUND INFECTION	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations CELLULITIS	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations INCISION SITE INFECTION	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations NASOPHARYNGITIS	0.51% 5/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations INCISION SITE ABSCESS	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations PNEUMONIA	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations SINUSITIS	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations BRONCHITIS	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations BACTERAEMIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations CANDIDIASIS	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations FUNGAL INFECTION	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations GASTROENTERITIS VIRAL	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations WOUND INFECTION STAPHYLOCOCCAL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations ANAL TINEA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations CYSTITIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations FOLLICULITIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations GASTROENTERITIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations INFECTION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations KIDNEY INFECTION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations ORAL HERPES	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations OSTEOMYELITIS ACUTE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations PHARYNGITIS STREPTOCOCCAL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations RESPIRATORY TRACT INFECTION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations TINEA PEDIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations TOOTH ABSCESS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications ANAEMIA POSTOPERATIVE	22.5% 218/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications INCISION SITE COMPLICATION	1.3% 13/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications POST PROCEDURAL OEDEMA	1.2% 12/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications INCISION SITE ERYTHEMA	0.93% 9/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications POST PROCEDURAL DISCHARGE	0.82% 8/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.62% 6/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications INCISION SITE HAEMORRHAGE	0.72% 7/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications CONTUSION	0.51% 5/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications FALL	0.62% 6/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications INCISION SITE OEDEMA	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications PROCEDURAL HYPOTENSION	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications SEROMA	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications SKIN LACERATION	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications EXCORIATION	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications INCISION SITE PAIN	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications POSTOPERATIVE WOUND COMPLICATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications PROCEDURAL NAUSEA	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications ESCHAR	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications FRACTURE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications HIP FRACTURE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications INCISION SITE BLISTER	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications LIGAMENT RUPTURE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications PROCEDURAL HYPERTENSION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications PROCEDURAL SITE REACTION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications PROCEDURAL VOMITING	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications THERMAL BURN	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications WOUND COMPLICATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications WOUND SECRETION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	6.3% 61/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations PROTHROMBIN TIME PROLONGED	1.4% 14/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD CREATININE INCREASED	0.72% 7/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations URINE OUTPUT DECREASED	1.0% 10/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	0.82% 8/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BREATH SOUNDS ABNORMAL	0.82% 8/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations OXYGEN SATURATION DECREASED	0.72% 7/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BODY TEMPERATURE INCREASED	0.62% 6/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations LIVER FUNCTION TEST ABNORMAL	0.51% 5/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.51% 5/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD AMYLASE INCREASED	0.51% 5/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD GLUCOSE INCREASED	0.51% 5/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations LIPASE INCREASED	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD BILIRUBIN INCREASED	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD MAGNESIUM DECREASED	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD CREATINE PHOSPHOKINASE MB INCREASED	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD UREA INCREASED	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations ELECTROCARDIOGRAM QT PROLONGED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations HEART RATE IRREGULAR	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations PLATELET COUNT DECREASED	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations RESPIRATORY RATE DECREASED	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations RESPIRATORY RATE INCREASED	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations WHITE BLOOD CELL COUNT INCREASED	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD ALBUMIN DECREASED	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD ALBUMIN INCREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD ALKALINE PHOSPHATASE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD ALKALINE PHOSPHATASE DECREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD PRESSURE DECREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD PRESSURE INCREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD URINE PRESENT	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations CAROTID BRUIT	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations CHEST X-RAY ABNORMAL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations CREATININE RENAL CLEARANCE DECREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations ELECTROCARDIOGRAM ST SEGMENT ABNORMAL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations ELECTROCARDIOGRAM T WAVE ABNORMAL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations FIBRIN D DIMER INCREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations HAEMATOCRIT DECREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations HAEMOGLOBIN DECREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations HEART RATE INCREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations HEPATIC ENZYME INCREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations PROTEIN TOTAL DECREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations PROTEIN TOTAL INCREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPOKALAEMIA	3.8% 37/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPERGLYCAEMIA	1.3% 13/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPONATRAEMIA	1.3% 13/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPOCALCAEMIA	0.93% 9/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPERKALAEMIA	0.51% 5/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.51% 5/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders DEHYDRATION	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPOALBUMINAEMIA	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPOPROTEINAEMIA	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders ANOREXIA	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders DECREASED APPETITE	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders DIABETES MELLITUS	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPOCHLORAEMIA	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders FLUID RETENTION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders GOUT	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPERCALCAEMIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPERCHOLESTEROLAEMIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPERMAGNESAEMIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders HYPOVOLAEMIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders IMPAIRED FASTING GLUCOSE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders KWASHIORKOR	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders METABOLIC ACIDOSIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders TYPE 2 DIABETES MELLITUS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders VITAMIN B12 DEFICIENCY	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	3.5% 34/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	1.6% 16/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.62% 6/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders BACK PAIN	0.72% 7/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.72% 7/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders JOINT SWELLING	0.62% 6/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders MUSCLE TIGHTNESS	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders NECK PAIN	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders ARTHROFIBROSIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders COSTOCHONDRITIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders EXOSTOSIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders GROIN PAIN	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders HYPERCREATINAEMIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders JOINT EFFUSION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders JOINT RANGE OF MOTION DECREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders LIMB DISCOMFORT	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL DISCOMFORT	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders NECK MASS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN PAPILLOMA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID NEOPLASM	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders HEADACHE	5.8% 56/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders DIZZINESS	5.0% 49/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders HYPOAESTHESIA	1.2% 12/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders SOMNOLENCE	0.82% 8/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders PARAESTHESIA	0.62% 6/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders PERONEAL NERVE PALSY	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders LETHARGY	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders SEDATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders NEUROPATHY PERIPHERAL	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders SINUS HEADACHE	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders SYNCOPE	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders AURA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders CAROTID ARTERY STENOSIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders DYSGEUSIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders ENCEPHALOPATHY	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders LOSS OF CONSCIOUSNESS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders MEMORY IMPAIRMENT	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders MOTOR DYSFUNCTION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders NERVE COMPRESSION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders SYNCOPE VASOVAGAL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Nervous system disorders TREMOR	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders INSOMNIA	13.4% 130/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders ANXIETY	2.3% 22/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders CONFUSIONAL STATE	0.93% 9/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders MENTAL STATUS CHANGES	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders AGITATION	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders DEPRESSION	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders HALLUCINATION	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders RESTLESSNESS	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders ABNORMAL DREAMS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders DELIRIUM TREMENS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders DISORIENTATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders FLAT AFFECT	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders HALLUCINATION, VISUAL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Psychiatric disorders NIGHTMARE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders URINARY RETENTION	2.2% 21/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders RENAL FAILURE ACUTE	0.51% 5/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders BLADDER SPASM	0.62% 6/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders DYSURIA	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders HAEMATURIA	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders RENAL FAILURE	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders INCONTINENCE	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders OLIGURIA	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders URINARY INCONTINENCE	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders ANURIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders AZOTAEMIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders BLADDER DISCOMFORT	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders BLADDER DISORDER	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders RENAL CYST	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders RENAL DISORDER	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Renal and urinary disorders UROGENITAL FISTULA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Reproductive system and breast disorders TESTICULAR OEDEMA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Reproductive system and breast disorders VAGINAL DISCHARGE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Reproductive system and breast disorders VULVOVAGINAL BURNING SENSATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PHARYNGOLARYNGEAL PAIN	2.9% 28/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	1.5% 15/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders COUGH	1.4% 14/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	1.1% 11/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.62% 6/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.51% 5/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders WHEEZING	0.62% 6/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders DYSPHONIA	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders HICCUPS	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders NASAL DRYNESS	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DEPRESSION	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders TACHYPNOEA	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders NASAL DISCOMFORT	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PHARYNGEAL OEDEMA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PLEURITIC PAIN	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PULMONARY GRANULOMA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders RALES	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Respiratory, thoracic and mediastinal disorders SPUTUM DISCOLOURED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders PRURITUS	12.9% 125/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders BLISTER	1.1% 11/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	0.93% 9/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.72% 7/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders RASH	0.72% 7/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders PRURITUS GENERALISED	0.62% 6/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders ERYTHEMA	0.41% 4/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders DERMATITIS	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders SKIN DISCOLOURATION	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders ALOPECIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders DRY SKIN	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders ECCHYMOSIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders ECZEMA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders HYPOAESTHESIA FACIAL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders INGROWING NAIL	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders LEUKOCYTOCLASTIC VASCULITIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders PSORIASIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders RASH PAPULAR	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders ROSACEA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders STASIS DERMATITIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders SWELLING FACE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders URTICARIA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Vascular disorders HYPOTENSION	6.1% 59/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Vascular disorders HYPERTENSION	3.4% 33/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Vascular disorders DEEP VEIN THROMBOSIS	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Vascular disorders FLUSHING	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Vascular disorders WOUND HAEMORRHAGE	0.31% 3/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Vascular disorders DIASTOLIC HYPOTENSION	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Vascular disorders HAEMATOMA	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Vascular disorders HOT FLUSH	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Vascular disorders HYPERTENSIVE CRISIS	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Vascular disorders PALLOR	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Infections and infestations VAGINAL INFECTION	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications INCISION SITE HAEMATOMA	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Injury, poisoning and procedural complications DEPRESSION POSTOPERATIVE	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	0.10% 1/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.
Skin and subcutaneous tissue disorders RASH PRURITIC	0.21% 2/971 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Any clinical significant changes in laboratory examinations were reported as AEs. Safety population included all participants who had received DIC075V and had at least 1 safety assessment.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER